Scholars@Duke
Michael Cohen-Wolkowiez

Michael Cohen-Wolkowiez

Kiser-Arena Distinguished Professor
Pediatrics, Infectious Diseases
michael.cohenwolkowiez@duke.edu
300 West Morgan Street, Box 3850, Durham, NC 27701
300 West Morgan Street, Box 3850, Durham, NC 27701

Selected Publications

Metronidazole exposure-response and safety in infants.

Journal Article Antimicrob Agents Chemother · November 5, 2025 The nitroimidazole antibiotic, metronidazole, is frequently prescribed to infants with serious intra-abdominal infections, and multiple dosing recommendations exist. We sought to evaluate the extent to which metronidazole doses and associated exposures ach ... Full text Link to item Cite

Population Pharmacokinetics of Meropenem Across the Adult Lifespan.

Journal Article Clin Pharmacokinet · February 2025 BACKGROUND AND OBJECTIVE: We conducted an opportunistic pharmacokinetic study to evaluate the population pharmacokinetics of meropenem, an antimicrobial commonly used to treat Gram-negative infections in adults of different ages, including older adults, an ... Full text Link to item Cite

A Pooled Pharmacokinetic Analysis for Piperacillin/Tazobactam Across Different Patient Populations: From Premature Infants to the Elderly.

Journal Article Clin Pharmacokinet · January 2025 BACKGROUND AND OBJECTIVES: The pharmacokinetics (PK) of piperacillin/tazobactam (PIP/TAZ) is highly variable across different patient populations and there are controversies regarding non-linear elimination as well as the fraction unbound of PIP (fUNB_PIP) ... Full text Link to item Cite

Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct-to-Family Pilot Trial.

Journal Article ACR Open Rheumatol · January 2025 OBJECTIVE: The objective of this study was to evaluate the preliminary effectiveness of an electronic pill bottle with automated reminders on hydroxychloroquine (HCQ) adherence in children with pediatric systemic lupus erythematosus (pSLE). METHODS: This w ... Full text Link to item Cite

Postdiscontinuation Antibiotic Exposure in Hospitalized Infants at Risk for Late-onset Sepsis in the Neonatal Intensive Care Unit.

Journal Article Pediatr Infect Dis J · October 1, 2024 BACKGROUND: In the neonatal intensive care unit, infants are at risk for late-onset sepsis. When blood cultures are negative, antibiotic stewardship efforts encourage stopping antibiotics, yet the duration of therapeutic exposure after the last dose is unk ... Full text Link to item Cite

Indomethacin Pharmacokinetics and Pharmacodynamics in Pregnancies With Preterm Labor: The Need for Dose-Ranging Trials.

Journal Article J Clin Pharmacol · June 2024 The use of indomethacin to delay delivery in preterm labor (PTL) is widely accepted; however, the optimal dosage of indomethacin in pregnancy is unknown. Here, we perform population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, characterize the p ... Full text Link to item Cite

Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.

Journal Article Antimicrob Agents Chemother · April 3, 2024 Pharmacokinetic models rarely undergo external validation in vulnerable populations such as critically ill infants, thereby limiting the accuracy, efficacy, and safety of model-informed dosing in real-world settings. Here, we describe an opportunistic appr ... Full text Open Access Link to item Cite

Identifying a stable and generalizable factor structure of major depressive disorder across three large longitudinal cohorts.

Journal Article Psychiatry Res · March 2024 The Patient Health Questionnaire 9 (PHQ-9) is the current standard outpatient screening tool for measuring and tracking the nine symptoms of major depressive disorder (MDD). While the PHQ-9 was originally conceptualized as a unidimensional measure, it has ... Full text Open Access Link to item Cite

Association of neighborhood-level sociodemographic factors with Direct-to-Consumer (DTC) distribution of COVID-19 rapid antigen tests in 5 US communities.

Journal Article BMC Public Health · September 22, 2023 BACKGROUND: Many interventions for widescale distribution of rapid antigen tests for COVID-19 have utilized online, direct-to-consumer (DTC) ordering systems; however, little is known about the sociodemographic characteristics of home-test users. We aimed ... Full text Link to item Cite

RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations.

Journal Article J Clin Microbiol · August 23, 2023 Research on the COVID-19 pandemic revealed a disproportionate burden of COVID-19 infection and death among underserved populations and exposed low rates of SARS-CoV-2 testing in these communities. A landmark National Institutes of Health (NIH) funding init ... Full text Open Access Link to item Cite

Association between simulated ketamine exposures and oxygen saturations in children.

Journal Article Int J Pharmacokinet · February 2023 AIM: We performed a real-world data analysis to evaluate the relationship between simulated ketamine exposures and oxygen desaturation in children. MATERIALS & METHODS: A previously developed population pharmacokinetic model was used to simulate exposures ... Full text Open Access Link to item Cite

Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan.

Journal Article Clin Pharmacokinet · January 2023 BACKGROUND AND OBJECTIVE: Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. Using an opportunistic study design, we evaluated the pharmacokinetics of piperacillin/tazobactam as a probe drug to evaluate changes in an ... Full text Link to item Cite

Say Yes! COVID Test: A Health Communication Campaign to Encourage Use of Rapid, At-Home Antigen Testing in Underserved and Historically Marginalized Communities.

Journal Article Inquiry · 2023 This paper describes a robust health communication campaign that supported Say Yes! COVID Test, the first National Institutes of Health (NIH)-sponsored initiative promoting community-wide, at-home, rapid antigen testing for severe acute respiratory syndrom ... Full text Link to item Cite

Adapting the Evidence Academy model for virtual stakeholder engagement in a national setting during the COVID-19 pandemic.

Journal Article J Clin Transl Sci · 2023 The COVID-19 pandemic raised the importance of adaptive capacity and preparedness when engaging historically marginalized populations in research and practice. The Rapid Acceleration of Diagnostics in Underserved Populations' COVID-19 Equity Evidence Acade ... Full text Link to item Cite

Access to COVID-19 testing by individuals with housing insecurity during the early days of the COVID-19 pandemic in the United States: a scoping review.

Journal Article Front Public Health · 2023 INTRODUCTION: The COVID-19 pandemic focused attention on healthcare disparities and inequities faced by individuals within marginalized and structurally disadvantaged groups in the United States. These individuals bore the heaviest burden across this pande ... Full text Open Access Link to item Cite

Exploring barriers and facilitators of implementing an at-home SARS-CoV-2 antigen self-testing intervention: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) initiatives.

Journal Article PLoS One · 2023 BACKGROUND: Evaluating community-based programs provides value to researchers, funding entities, and community stakeholders involved in program implementation, and can increase program impact and sustainability. To understand factors related to program imp ... Full text Link to item Cite

Use of Electronic Health Records to Identify Exposure-Response Relationships in Critically Ill Children: An Example of Midazolam and Delirium.

Journal Article J Pediatr Intensive Care · December 2022 Adverse drug events are common in critically ill children and often result from systemic or target organ drug exposure. Methods of drug dosing and titration that consider pharmacokinetic alterations may improve our ability to optimally dose critically ill ... Full text Link to item Cite

Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial.

Journal Article Lupus Sci Med · November 2022 OBJECTIVE: Determine the pharmacokinetics (PK) and exposure-response of hydroxychloroquine (HCQ) and desethylhydroxychloroquine (DHCQ) in paediatric SLE (pSLE). METHODS: We conducted an exploratory phase 2, direct-to-family trial. Children enrolled in the ... Full text Link to item Cite

Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.

Journal Article Prev Med Rep · October 2022 Inequalities around COVID-19 testing and vaccination persist in the U.S. health system. We investigated whether a community-engaged approach could be used to distribute free, at-home, rapid SARS-CoV-2 tests to underserved populations. Between November 18-D ... Full text Open Access Link to item Cite

Safety and Pharmacokinetics of Exebacase in an Infant With Disseminated Staphylococcus aureus Infection.

Journal Article Clin Infect Dis · August 25, 2022 Exebacase, an antistaphylococcal lysin produced from a bacteriophage-encoded gene, is a promising adjunctive therapy for severe methicillin-resistant Staphylococcus aureus infections. We describe the first infant to receive exebacase, dosing, and pharmacok ... Full text Open Access Link to item Cite

Standardizing, harmonizing, and protecting data collection to broaden the impact of COVID-19 research: the rapid acceleration of diagnostics-underserved populations (RADx-UP) initiative.

Journal Article J Am Med Inform Assoc · August 16, 2022 OBJECTIVE: The Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program is a consortium of community-engaged research projects with the goal of increasing access to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tests in un ... Full text Link to item Cite

Use of a Digital Assistant to Report COVID-19 Rapid Antigen Self-test Results to Health Departments in 6 US Communities.

Journal Article JAMA Netw Open · August 1, 2022 IMPORTANCE: Widespread distribution of rapid antigen tests is integral to the US strategy to address COVID-19; however, it is estimated that few rapid antigen test results are reported to local departments of health. OBJECTIVE: To characterize how often in ... Full text Open Access Link to item Cite

Ampicillin dosing in premature infants for early-onset sepsis: exposure-driven efficacy, safety, and stewardship.

Journal Article J Perinatol · July 2022 OBJECTIVE: Define optimal ampicillin dosing for empiric early-onset sepsis (EOS) therapy in preterm neonates. STUDY DESIGN: We simulated ampicillin concentrations in newborns (birthweight < 1500 g; gestational age 22-27 weeks), summarizing three 48 h regim ... Full text Link to item Cite

Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.

Journal Article Pediatr Infect Dis J · July 1, 2022 BACKGROUND: Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP. METHODS: This phase ... Full text Open Access Link to item Cite

The relationship between simulated milrinone exposure and hypotension in children.

Journal Article Cardiol Young · May 2022 INTRODUCTION: Hypotension is an adverse event that may be related to systemic exposure of milrinone; however, the true exposure-safety relationship is unknown. METHODS: Using the Pediatric Trials Network multicentre repository, we identified children ≤17 y ... Full text Link to item Cite

First-in-Human Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Doses of NTM-1633, a Novel Mixture of Monoclonal Antibodies against Botulinum Toxin E.

Journal Article Antimicrob Agents Chemother · April 19, 2022 Botulism is a rare, life-threatening paralytic disease caused by botulinum neurotoxin (BoNT). Available treatments including an equine antitoxin and human immune globulin are given postexposure and challenging to produce and administer. NTM-1633 is an equi ... Full text Link to item Cite

Association of Mass Distribution of Rapid Antigen Tests and SARS-CoV-2 Prevalence: Results from NIH-CDC funded Say Yes! Covid Test program in Michigan.

Journal Article medRxiv · April 2, 2022 IMPORTANCE: Wide-spread distribution of diagnostics is an integral part of the United States’ COVID-19 strategy; however, few studies have assessed the effectiveness of this intervention at reducing transmission of community COVID-19. OBJECTIVE: To asses ... Full text Link to item Cite

Adverse Reactions in a Phase 1 Trial of the Anti-Malarial DM1157: An Example of Pharmacokinetic Modeling and Simulation Guiding Clinical Trial Decisions.

Journal Article Infect Dis Ther · April 2022 INTRODUCTION: There is an urgent need to develop new drugs to treat malaria due to increasing resistance to first-line therapeutics targeting the causative organism, Plasmodium falciparum (P. falciparum). One drug candidate is DM1157, a small molecule that ... Full text Link to item Cite

If you build it, will they use it? Use of a Digital Assistant for Self-Reporting of COVID-19 Rapid Antigen Test Results during Large Nationwide Community Testing Initiative.

Journal Article medRxiv · April 1, 2022 IMPORTANCE: Wide-spread distribution of rapid-antigen tests is integral to the United States' strategy to address COVID-19; however, it is estimated that few rapid-antigen test results are reported to local departments of health. OBJECTIVE: To characterize ... Full text Link to item Cite

Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.

Journal Article Clin Pharmacokinet · February 2022 BACKGROUND AND OBJECTIVE: While one in five children in the USA are now obese, and more than three-quarters receive at least one drug during childhood, there is limited dosing guidance for this vulnerable patient population. Physiologically based pharmacok ... Full text Link to item Cite

Safety of sildenafil in extremely premature infants: a phase I trial.

Journal Article J Perinatol · January 2022 OBJECTIVE: To characterize the safety of sildenafil in premature infants. STUDY DESIGN: A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (coho ... Full text Link to item Cite

Hydroxychloroquine PK and exposure-response in pregnancies with lupus: the importance of adherence for neonatal outcomes.

Journal Article Lupus Sci Med · January 2022 OBJECTIVE: Evaluate the impact of pregnancy physiology and medication non-adherence on serum hydroxychloroquine (HCQ) pharmacokinetics (PK) and exposure-response in SLE. METHODS: We conducted a PK analysis using data from two observational pregnancy regist ... Full text Link to item Cite

At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.

Journal Article BMC Public Health · December 4, 2021 BACKGROUND: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve as a global health crisis. Although highly effective vaccines have been developed, non-pharmaceutical interventions remain crit ... Full text Link to item Cite

Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants.

Conference Clin Pharmacokinet · December 2021 BACKGROUND: Meropenem is a broad-spectrum carbapenem antibiotic approved by the US Food and Drug Administration for use in pediatric patients, including treating complicated intra-abdominal infections in infants < 3 months of age. The impact of maturation ... Full text Link to item Cite

Leveraging Physiologically Based Pharmacokinetic Modeling and Experimental Data to Guide Dosing Modification of CYP3A-Mediated Drug-Drug Interactions in the Pediatric Population.

Journal Article Drug Metab Dispos · September 2021 Solithromycin is a novel fluoroketolide antibiotic that is both a substrate and time-dependent inhibitor of CYP3A. Solithromycin has demonstrated efficacy in adults with community-acquired bacterial pneumonia and has also been investigated in pediatric pat ... Full text Link to item Cite

External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.

Journal Article Antimicrob Agents Chemother · June 17, 2021 The antibiotic combination trimethoprim (TMP)-sulfamethoxazole (SMX) has a broad spectrum of activity and is used for the treatment of numerous infections, but pediatric pharmacokinetic (PK) data are limited. We previously published population PK (popPK) m ... Full text Link to item Cite

Safety, Tolerability, and Pharmacokinetics of NTM-1632, a Novel Mixture of Three Monoclonal Antibodies against Botulinum Toxin B.

Journal Article Antimicrob Agents Chemother · June 17, 2021 Botulism is a rare, life-threatening paralytic disease caused by Clostridium botulinum neurotoxin (BoNT). Available treatments, including an equine antitoxin and human immune globulin, are given postexposure and challenging to produce and administer. NTM-1 ... Full text Link to item Cite

Optimal Dosing of Meropenem in a Small Cohort of Critically Ill Children Receiving Continuous Renal Replacement Therapy.

Journal Article J Clin Pharmacol · June 2021 Severe sepsis is an important cause of mortality and morbidity in critically ill children. Meropenem is a broad-spectrum antibiotic commonly used to treat sepsis. Current meropenem dosage recommendations for children on continuous renal replacement therapy ... Full text Link to item Cite

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.

Journal Article Pediatr Infect Dis J · June 1, 2021 BACKGROUND: In premature infants, complicated intraabdominal infections (cIAIs) are a leading cause of morbidity and mortality. Although universally prescribed, the safety and effectiveness of commonly used antibiotic regimens have not been established in ... Full text Link to item Cite

Prolonged Post-Discontinuation Antibiotic Exposure in Very Low Birth Weight Neonates at Risk for Early-Onset Sepsis.

Journal Article J Pediatric Infect Dis Soc · May 28, 2021 BACKGROUND: Premature, very low birth weight (VLBW) neonates are at risk for early-onset sepsis and receive ampicillin and gentamicin post-birth. Antimicrobial stewardship supports short-course antibiotics, but how long antibiotic concentrations remain the ... Full text Link to item Cite

A systematic review of the evidence supporting post-operative medication use in congenital heart disease.

Journal Article Cardiol Young · May 2021 BACKGROUND: Targeted drug development efforts in patients with CHD are needed to standardise care, improve outcomes, and limit adverse events in the post-operative period. To identify major gaps in knowledge that can be addressed by drug development effort ... Full text Link to item Cite

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.

Journal Article Lupus Sci Med · May 2021 INTRODUCTION: Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designi ... Full text Link to item Cite

Pharmacokinetics of Hydrochlorothiazide in Children: A Potential Surrogate for Renal Secretion Maturation.

Journal Article J Clin Pharmacol · March 2021 Hydrochlorothiazide (HCTZ) is a thiazide diuretic used in adults and children for the treatment of hypertension and edema. The pharmacokinetic (PK) properties of HCTZ in children are not well characterized, particularly among children with obesity who freq ... Full text Link to item Cite

Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.

Journal Article Clin Transl Sci · March 2021 Obesity is a prevalent childhood condition and the degree of adiposity appears likely to be an important covariate in the pharmacokinetics (PKs) of many drugs. We undertook these studies to facilitate the evaluation and, where appropriate, quantification o ... Full text Link to item Cite

Population pharmacokinetics of olanzapine in children.

Journal Article Br J Clin Pharmacol · February 2021 AIMS: The aim of this study was to evaluate the population pharmacokinetics (PopPK) of olanzapine in children and devise a model-informed paediatric dosing scheme. METHODS: The PopPK of olanzapine was characterized using opportunistically collected plasma ... Full text Link to item Cite

Population Pharmacokinetics of Metoclopramide in Infants, Children, and Adolescents.

Journal Article Clin Transl Sci · November 2020 Metoclopramide is commonly used for gastroesophageal reflux. The aims of the present study were to develop a pediatric population pharmacokinetic (PopPK) model, which was applied to simulate the metoclopramide exposure following dosing used in clinical pra ... Full text Link to item Cite

Dr. Balevic, et al reply.

Journal Article J Rheumatol · October 1, 2020 Full text Link to item Cite

Simulated Assessment of Pharmacokinetically Guided Dosing for Investigational Treatments of Pediatric Patients With Coronavirus Disease 2019.

Journal Article JAMA Pediatr · October 1, 2020 IMPORTANCE: Children of all ages appear susceptible to severe acute respiratory syndrome coronavirus 2 infection. To support pediatric clinical studies for investigational treatments of coronavirus disease 2019 (COVID-19), pediatric-specific dosing is requ ... Full text Link to item Cite

Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections.

Journal Article Pediatr Infect Dis J · September 2020 BACKGROUND: Metronidazole is frequently used off-label in infants with complicated intra-abdominal infections (cIAI) to provide coverage against anaerobic organisms, but its safety and efficacy in this indication are unknown. METHODS: In the Antibiotic Saf ... Full text Link to item Cite

Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis.

Journal Article Clin Pharmacol Ther · August 2020 In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships b ... Full text Link to item Cite

Paradoxical Antibiotic Effect of Ampicillin: Use of a Population Pharmacokinetic Model to Evaluate a Clinical Correlate of the Eagle Effect in Infants With Bacteremia.

Journal Article Pediatr Infect Dis J · August 2020 BACKGROUND: High doses of ampicillin are often used to achieve therapeutic drug concentrations in infants. A paradoxical antibiotic effect, often called the Eagle effect, occurs when increasing concentrations of antibiotic above a threshold results in decr ... Full text Link to item Cite

Dosing of Antimicrobials in the Neonatal Intensive Care Unit: Does Clinical Practice Reflect Pharmacokinetics-based Recommendations?

Journal Article Pediatr Infect Dis J · August 2020 BACKGROUND: We sought to compare meropenem and fluconazole dosing in the neonatal intensive care unit with recommendations based on published pharmacokinetic (PK) studies in infants. METHODS: We performed an observational cohort study of infants <90 days p ... Full text Link to item Cite

Use of normalized prediction distribution errors for assessing population physiologically-based pharmacokinetic model adequacy.

Journal Article J Pharmacokinet Pharmacodyn · June 2020 Currently employed methods for qualifying population physiologically-based pharmacokinetic (Pop-PBPK) model predictions of continuous outcomes (e.g., concentration-time data) fail to account for within-subject correlations and the presence of residual erro ... Full text Link to item Cite

Hydroxychloroquine in Patients with Rheumatic Disease Complicated by COVID-19: Clarifying Target Exposures and the Need for Clinical Trials.

Journal Article J Rheumatol · May 11, 2020 OBJECTIVE: To characterize hydroxychloroquine (HCQ) exposure in patients with rheumatic disease receiving longterm HCQ compared to target concentrations with reported antiviral activity against the coronavirus disease 2019 caused by SARS-CoV-2 (COVID-19). ... Full text Link to item Cite

A Pharmacoepidemiologic Study of the Safety and Effectiveness of Clindamycin in Infants.

Journal Article Pediatr Infect Dis J · March 2020 BACKGROUND: Despite the absence of adequate safety or efficacy data, clindamycin is widely prescribed in the neonatal intensive care unit. We evaluated the association between clindamycin exposure and adverse events, as well as antibiotic effectiveness in ... Full text Link to item Cite

Development of a Prospective Real-World Data Clinical Registry of Children and Adolescents With Migraine.

Journal Article Headache · February 2020 OBJECTIVE: To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infra ... Full text Link to item Cite

Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents.

Journal Article J Clin Pharmacol · December 2019 Milrinone is a type 3 phosphodiesterase inhibitor used to improve cardiac output in critically ill infants and children. Milrinone is primarily excreted unchanged in the urine, raising concerns for toxic accumulation in the setting of renal dysfunction of ... Full text Link to item Cite

A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.

Journal Article Ther Drug Monit · December 2019 BACKGROUND: Solithromycin is a fourth-generation macrolide antibiotic with potential efficacy in pediatric community-acquired bacterial pneumonia. Pharmacokinetic (PK) studies of solithromycin in pediatric subjects are limited, therefore application of min ... Full text Link to item Cite

Population pharmacokinetics of sildenafil in extremely premature infants.

Journal Article Br J Clin Pharmacol · December 2019 AIMS: To characterize the population pharmacokinetics (PK) of sildenafil and its active metabolite, N-desmethyl sildenafil (DMS), in premature infants. METHODS: We performed a multicentre, open-label trial to characterize the PK of sildenafil in infants ≤2 ... Full text Link to item Cite

Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.

Journal Article CPT Pharmacometrics Syst Pharmacol · December 2019 Methylprednisolone is used in neonates to modulate cardiopulmonary bypass (CPB)-induced inflammation, but optimal dosing and exposure are unknown. We used plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations from neonates enrolled in a ... Full text Link to item Cite

Dexmedetomidine Pharmacokinetics and a New Dosing Paradigm in Infants Supported With Cardiopulmonary Bypass.

Journal Article Anesth Analg · December 2019 BACKGROUND: Dexmedetomidine is increasingly used off-label in infants and children with cardiac disease during cardiopulmonary bypass (CPB) and in the postoperative period. Despite its frequent use, optimal dosing of dexmedetomidine in the setting of CPB h ... Full text Link to item Cite

Predicting the pharmacokinetics of piperacillin and tazobactam in preterm and term neonates using physiologically based pharmacokinetic modeling

Journal Article Computational Toxicology · November 1, 2019 A probabilistic-based seven-compartment fit for purpose PBPK model for the preterm and term neonates was constructed and used with the combination antimicrobial drugs piperacillin (PIP) and tazobactam (TAZ) as a case study. Anthropomorphic maturation equat ... Full text Cite

Population Pharmacokinetics of Doxycycline in Children.

Journal Article Antimicrob Agents Chemother · September 9, 2019 Doxycycline is a tetracycline-class antimicrobial labeled by the United States (U.S.) Food and Drug Administration for children >8 years of age for many common childhood infections. Doxycycline is not labeled for children ≤8 years of age, due to the associ ... Full text Link to item Cite

Cefazolin pharmacokinetics in premature infants.

Journal Article J Perinatol · September 2019 OBJECTIVE: Pharmacokinetic (PK) data to guide cefazolin dosing in premature infants are virtually non-existent. Therefore, we aimed to characterize cefazolin PK in infants aged ≤32 weeks of gestation at birth. STUDY DESIGN: We conducted a prospective, open ... Full text Link to item Cite

Physiologically-Based Pharmacokinetic Modeling of Fluconazole Using Plasma and Cerebrospinal Fluid Samples From Preterm and Term Infants.

Conference CPT Pharmacometrics Syst Pharmacol · July 2019 Fluconazole is used to treat hematogenous Candida meningoencephalitis in preterm and term infants. To characterize plasma and central nervous system exposure, an adult fluconazole physiologically-based pharmacokinetic (PBPK) model was scaled to infants, ac ... Full text Link to item Cite

Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.

Journal Article Clin Pharmacokinet · July 2019 OBJECTIVE: The aims of this study were to (1) determine whether opportunistically collected data can be used to develop physiologically based pharmacokinetic (PBPK) models in pediatric patients; and (2) characterize age-related maturational changes in drug ... Full text Link to item Cite

Rifampin Pharmacokinetics and Safety in Preterm and Term Infants.

Journal Article Antimicrob Agents Chemother · June 2019 Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of <121 days postnatal age (PNA). We enrolled 27 ... Full text Link to item Cite

Pitfalls of using numerical predictive checks for population physiologically-based pharmacokinetic model evaluation.

Journal Article J Pharmacokinet Pharmacodyn · June 2019 Comparisons between observed data and model simulations represent a critical component for establishing confidence in population physiologically-based pharmacokinetic (Pop-PBPK) models. Numerical predictive checks (NPC) that assess the proportion of observ ... Full text Link to item Cite

Pharmacokinetics of ticarcillin-clavulanate in premature infants.

Journal Article Br J Clin Pharmacol · May 2019 Ticarcillin-clavulanate covers a broad spectrum of pathogens that are common in premature infants. In infants <30 weeks gestational age, pharmacokinetic data to guide ticarcillin-clavulanate dosing are lacking. We enrolled 15 premature infants <30 weeks ge ... Full text Link to item Cite

Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases.

Journal Article Clin Pharmacokinet · April 2019 BACKGROUND: Hydroxychloroquine is an oral drug prescribed to pregnant women with rheumatic disease to reduce disease activity and prevent flares. Physiologic changes during pregnancy may substantially alter drug pharmacokinetics. However, the effect of pre ... Full text Link to item Cite

Safety, Effectiveness and Exposure-response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records.

Journal Article Pediatr Infect Dis J · February 2019 Micafungin is used off-label in the United States to treat invasive candidiasis in neonates. We used an established pharmacokinetic model to determine micafungin exposures for 46 courses in 39 hospitalized infants. In this small cohort of infants, micafung ... Full text Link to item Cite

Hydroxychloroquine Levels throughout Pregnancies Complicated by Rheumatic Disease: Implications for Maternal and Neonatal Outcomes.

Journal Article J Rheumatol · January 2019 OBJECTIVE: Pregnancies in women with active rheumatic disease often result in poor neonatal outcomes. Hydroxychloroquine (HCQ) reduces disease activity and flares; however, pregnancy causes significant physiologic changes that may alter HCQ levels and lead ... Full text Link to item Cite

Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status Epilepticus.

Journal Article CPT Pharmacometrics Syst Pharmacol · November 2018 Diazepam is labeled for status epilepticus (SE) in children, but there are limited data characterizing its disposition in pediatric patients. We developed a population pharmacokinetic (PK) model of i.v. diazepam in children with SE. We evaluated relationsh ... Full text Link to item Cite

Physiologically Based Pharmacokinetic Approach to Determine Dosing on Extracorporeal Life Support: Fluconazole in Children on ECMO.

Journal Article CPT Pharmacometrics Syst Pharmacol · October 2018 Extracorporeal life support (e.g., dialysis, extracorporeal membrane oxygenation (ECMO)) can affect drug disposition, placing patients at risk for therapeutic failure. In this population, dose selection to achieve safe and effective drug exposure is diffic ... Full text Link to item Cite

A Population-Based Pharmacokinetic Model Approach to Pantoprazole Dosing for Obese Children and Adolescents.

Journal Article Paediatr Drugs · October 2018 BACKGROUND AND AIMS: Pharmacokinetic data for proton pump inhibitors (PPIs), acid-suppression drugs commonly prescribed to children, are lacking for obese children who are at greatest risk for acid-related disease. In a recent multi-center investigation, w ... Full text Link to item Cite

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.

Journal Article J Clin Pharmacol · October 2018 Almost half of recent pediatric trials failed to achieve labeling indications, in large part because of inadequate study design. Therefore, innovative study methods are crucial to optimizing trial design while also reducing the potential harms inherent wit ... Full text Link to item Cite

Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis.

Journal Article Pediatr Infect Dis J · September 2018 BACKGROUND: Invasive candidiasis is an important cause of sepsis in extremely low birth weight infants (ELBW, < 1000 g), is often fatal, and frequently results in neurodevelopmental impairment (NDI) among survivors. We sought to assess the antifungal minim ... Full text Link to item Cite

External Evaluation of a Gentamicin Infant Population Pharmacokinetic Model Using Data from a National Electronic Health Record Database.

Journal Article Antimicrob Agents Chemother · September 2018 Gentamicin is a common antibiotic used in neonates and infants. A recently published population pharmacokinetic (PK) model was developed using data from multiple studies, and the objective of our analyses was to evaluate the feasibility of using a national ... Full text Link to item Cite

Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children.

Journal Article J Clin Pharmacol · August 2018 Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate dissociative anesthesia in children undergoing invasive procedures. Available for both intravenous and intramuscular administration, ketamine is commonly used when vascula ... Full text Link to item Cite

Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.

Journal Article Antimicrob Agents Chemother · August 2018 Solithromycin is a novel fluoroketolide antibiotic which was under investigation for the treatment of community-acquired bacterial pneumonia (CABP). A phase 1 study was performed to characterize the pharmacokinetics (PK) and safety of solithromycin in chil ... Full text Link to item Cite

Reply.

Journal Article J Pediatr · July 2018 Full text Link to item Cite

A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data.

Journal Article J Pharmacokinet Pharmacodyn · June 2018 Amiodarone is a first-line antiarrhythmic for life-threatening ventricular fibrillation or ventricular tachycardia in children, yet little is known about its pharmacokinetics (PK) in this population. We developed a population PK (PopPK) model using samples ... Full text Link to item Cite

Improving Pediatric Protein Binding Estimates: An Evaluation of α1-Acid Glycoprotein Maturation in Healthy and Infected Subjects.

Journal Article Clin Pharmacokinet · May 2018 BACKGROUND: Differences in plasma protein levels observed between children and adults can alter the extent of xenobiotic binding in plasma, resulting in divergent patterns of exposure. OBJECTIVE: This study aims to quantify the ontogeny of α1-acid glycopro ... Full text Link to item Cite

Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.

Journal Article Ther Drug Monit · February 2018 BACKGROUND: Dried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to determine the population pharmacokinetics (pop-PK) of ampicillin, as well as accuracy versus plasma samples, was evaluated. M ... Full text Link to item Cite

Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants.

Journal Article Cardiol Young · January 2018 BACKGROUND: The relationship between sildenafil dosing, exposure, and systemic hypotension in infants is incompletely understood. OBJECTIVES: The aim of this study was to characterise the relationship between predicted sildenafil exposure and hypotension i ... Full text Link to item Cite

Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children.

Journal Article Antimicrob Agents Chemother · January 2018 Trimethoprim (TMP)-sulfamethoxazole (SMX) is used to treat various types of infections, including community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) and Pneumocystis jirovecii infections in children. Pharmacokinetic (PK) data for infa ... Full text Link to item Cite

Antibiotic Dosing Considerations for Term and Preterm Infants

Chapter · January 1, 2018 Early and appropriate antibiotic therapy can be lifesaving for severe infections in infants. However, physiologic differences in infants compared with older children and adults contribute to challenges in neonatal dosing. Neonatal-specific dosing regimens ... Full text Cite

Development of an Adult Physiologically Based Pharmacokinetic Model of Solithromycin in Plasma and Epithelial Lining Fluid.

Journal Article CPT Pharmacometrics Syst Pharmacol · December 2017 Solithromycin is a fluoroketolide antibiotic under investigation for community-acquired bacterial pneumonia (CABP). We developed a whole-body physiologically based pharmacokinetic (PBPK) model for solithromycin in adults using PK-Sim and MoBi version 6.2, ... Full text Link to item Cite

External Evaluation of Two Fluconazole Infant Population Pharmacokinetic Models.

Journal Article Antimicrob Agents Chemother · December 2017 Fluconazole is an antifungal agent used for the treatment of invasive candidiasis, a leading cause of morbidity and mortality in premature infants. Population pharmacokinetic (PK) models of fluconazole in infants have been previously published by Wade et a ... Full text Link to item Cite

Development of a Pediatric Physiologically-Based Pharmacokinetic Model of Clindamycin Using Opportunistic Pharmacokinetic Data.

Journal Article Clin Pharmacokinet · November 2017 Physiologically-based pharmacokinetic (PBPK) modeling is a powerful tool used to characterize maturational changes in drug disposition to inform dosing across childhood; however, its use is limited in pediatric drug development. Access to pediatric pharmac ... Full text Link to item Cite

Clinical Trial Design in Juvenile Idiopathic Arthritis.

Journal Article Paediatr Drugs · October 2017 Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the i ... Full text Link to item Cite

Population Pharmacokinetics/Pharmacodynamics of 3,4-Diaminopyridine Free Base in Patients With Lambert-Eaton Myasthenia.

Conference CPT Pharmacometrics Syst Pharmacol · September 2017 Lambert-Eaton myasthenia (LEM) is a rare autoimmune disorder associated with debilitating muscle weakness. There are limited treatment options and 3,4-diaminopyridine (3,4-DAP) free base is an investigational orphan drug used to treat LEM-related weakness. ... Full text Link to item Cite

Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants.

Journal Article Pediatr Infect Dis J · September 2017 BACKGROUND: Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infa ... Full text Link to item Cite

Population Pharmacokinetics of Dexmedetomidine in Infants.

Journal Article J Clin Pharmacol · September 2017 Despite limited pharmacokinetic (PK) data, dexmedetomidine is increasingly being used off-label for sedation in infants. We aimed to characterize the developmental PK changes of dexmedetomidine during infancy. In this open-label, single-center PK study of ... Full text Link to item Cite

Dosing antibiotics in neonates: review of the pharmacokinetic data.

Journal Article Future Microbiol · September 2017 Antibiotics are often used in neonates despite the absence of relevant dosing information in drug labels. For neonatal dosing, clinicians must extrapolate data from studies for adults and older children, who have strikingly different physiologies. As a res ... Full text Link to item Cite

Antifungal Extraction by the Extracorporeal Membrane Oxygenation Circuit.

Journal Article J Extra Corpor Technol · September 2017 Invasive candidiasis is common and often fatal in patients supported with extracorporeal membrane oxygenation (ECMO), and treatment relies on optimal antifungal dosing. The ECMO circuit can extract drug and decrease drug exposure, placing the patient at ri ... Link to item Cite

Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.

Journal Article Clin Pharmacokinet · August 2017 BACKGROUND: Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and chil ... Full text Link to item Cite

Preexisting antibodies can protect against congenital cytomegalovirus infection in monkeys.

Journal Article JCI Insight · July 6, 2017 Human cytomegalovirus (HCMV) is the most common congenital infection and a known cause of microcephaly, sensorineural hearing loss, and cognitive impairment among newborns worldwide. Natural maternal HCMV immunity reduces the incidence of congenital infect ... Full text Link to item Cite

Dalbavancin Pharmacokinetics and Safety in Children 3 Months to 11 Years of Age.

Journal Article Pediatr Infect Dis J · July 2017 BACKGROUND: Dalbavancin is a novel lipoglycopeptide antibiotic that has potent in vitro activity against Gram-positive microorganisms. METHODS: We performed a phase 1, open-label, multicenter study to investigate the pharmacokinetics (PK) and safety of a s ... Full text Link to item Cite

Pharmacokinetics of Clindamycin in Obese and Nonobese Children.

Journal Article Antimicrob Agents Chemother · April 2017 Although obesity is prevalent among children in the United States, pharmacokinetic (PK) data for obese children are limited. Clindamycin is a commonly used antibiotic that may require dose adjustment in obese children due to its lipophilic properties. We p ... Full text Link to item Cite

A Systematic Literature Review Approach to Estimate the Therapeutic Index of Selected Immunosuppressant Drugs After Renal Transplantation.

Journal Article Ther Drug Monit · February 2017 BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence ... Full text Link to item Cite

Systemic administration of an HIV-1 broadly neutralizing dimeric IgA yields mucosal secretory IgA and virus neutralization.

Journal Article Mucosal Immunol · January 2017 We investigated the mucosal distribution and neutralization potency of rhesus recombinant versions of the HIV-specific, broadly neutralizing antibody b12 (RhB12) following intravenous administration to lactating rhesus monkeys. IgG and dimeric IgA (dIgA) a ... Full text Link to item Cite

Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine.

Journal Article Ther Drug Monit · December 2016 BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic ... Full text Link to item Cite

Pharmacokinetics and Safety of Micafungin in Infants Supported With Extracorporeal Membrane Oxygenation.

Journal Article Pediatr Infect Dis J · November 2016 BACKGROUND: Candida is a leading cause of infection in infants on extracorporeal membrane oxygenation (ECMO). Optimal micafungin dosing is unknown in this population because ECMO can alter drug pharmacokinetics (PK). METHODS: To characterize micafungin pha ... Full text Link to item Cite

Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.

Journal Article J Pediatr · November 2016 OBJECTIVE: To evaluate the relationship between ampicillin dosing, exposure, and seizures. STUDY DESIGN: This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure pr ... Full text Link to item Cite

Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients.

Journal Article Ther Drug Monit · October 2016 BACKGROUND: Sirolimus, an immunosuppressive agent used in renal transplantation, can prevent allograft rejection. Identification of the therapeutic index (the ratio of minimum toxic concentration to minimum therapeutic concentration) for immunosuppresants ... Full text Link to item Cite

An opportunistic study evaluating pharmacokinetics of sildenafil for the treatment of pulmonary hypertension in infants.

Journal Article J Perinatol · September 2016 OBJECTIVE: The objective of this study is to assess sildenafil and N-desmethyl sildenafil (DMS) exposure in infants receiving sildenafil for the treatment of pulmonary hypertension (PH). STUDY DESIGN: Data were collected from six infants receiving sildenaf ... Full text Link to item Cite

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.

Journal Article Clin Ther · September 2016 PURPOSE: Over the last decade, few new antibiotics have been approved by the Food and Drug Administration (FDA) for pediatric use. For most anti-infective agents, including antibiotics, extrapolation of efficacy from adults to children is possible if the d ... Full text Link to item Cite

Advances in Pediatric Pharmacology, Therapeutics, and Toxicology.

Journal Article Adv Pediatr · August 2016 In the United States, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act continue to promote clinical trials in pediatric populations across all age ranges. In 2014 and 2015, over 70 changes were made to drug labels with update ... Full text Link to item Cite

Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.

Journal Article Antimicrob Agents Chemother · May 2016 Clindamycin may be active against methicillin-resistant Staphylococcus aureus, a common pathogen causing sepsis in infants, but optimal dosing in this population is unknown. We performed a multicenter, prospective pharmacokinetic (PK) and safety study of c ... Full text Link to item Cite

Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.

Journal Article Antimicrob Agents Chemother · April 2016 We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum ... Full text Link to item Cite

Pharmacokinetics of intravenous sildenafil in children with palliated single ventricle heart defects: effect of elevated hepatic pressures.

Journal Article Cardiol Young · February 2016 UNLABELLED: Aims Sildenafil is frequently prescribed to children with single ventricle heart defects. These children have unique hepatic physiology with elevated hepatic pressures, which may alter drug pharmacokinetics. We sought to determine the impact of ... Full text Link to item Cite

Therapeutic Index Estimation of Antiepileptic Drugs: A Systematic Literature Review Approach.

Journal Article Clin Neuropharmacol · 2016 OBJECTIVES: Our study aimed to determine whether data obtained from the medical literature can be used to estimate the therapeutic index of 5 antiepileptic drugs (AEDs): carbamazepine, lamotrigine, phenobarbital, phenytoin, and valproate. METHODS: We perfo ... Full text Link to item Cite

Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats.

Conference J Nucl Med · November 2015 UNLABELLED: Intraarterial microdosing (IAM) is a novel drug development approach combining intraarterial drug delivery and microdosing. We aimed to demonstrate that IAM leads to target exposure similar to that of systemic full-dose administration but with ... Full text Link to item Cite

Pharmacologic studies in vulnerable populations: Using the pediatric experience.

Journal Article Semin Perinatol · November 2015 Historically, few data exist to guide dosing in children and pregnant women. Multiple barriers to inclusion of these vulnerable populations in clinical trials have led to this paucity of data. However, federal legislation targeted at pediatric therapeutics ... Full text Link to item Cite

Cefepime and Ceftazidime Safety in Hospitalized Infants.

Journal Article Pediatr Infect Dis J · September 2015 BACKGROUND: Cefepime and ceftazidime are cephalosporins used for the treatment of serious Gram-negative infections. These cephalosporins are used off-label in the setting of minimal safety data for young infants. METHODS: We identified all infants discharg ... Full text Link to item Cite

A Single-Arm Phase 1b Study of Everolimus and Sunitinib in Patients With Advanced Renal Cell Carcinoma.

Journal Article Clin Genitourin Cancer · August 2015 BACKGROUND: Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), and sunitinib, an oral inhibitor of vascular endothelial growth factor (VEGF)/platelet-derived growth factor receptor tyrosine kinase signaling, have both been shown to prov ... Full text Link to item Cite

Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation.

Journal Article Antimicrob Agents Chemother · July 2015 Candida infections are a leading cause of infectious disease-related death in children supported by extracorporeal membrane oxygenation (ECMO). The ECMO circuit can alter drug pharmacokinetics (PK); thus, standard fluconazole dosing may result in suboptima ... Full text Link to item Cite

Drug Dosing and Pharmacokinetics in Children With Obesity: A Systematic Review.

Journal Article JAMA Pediatr · July 2015 IMPORTANCE: Obesity affects nearly one-sixth of US children and results in alterations to body composition and physiology that can affect drug disposition, possibly leading to therapeutic failure or toxic side effects. The depth of available literature reg ... Full text Link to item Cite

Advances in the treatment of invasive neonatal candidiasis.

Journal Article Expert Opin Pharmacother · May 2015 INTRODUCTION: Invasive candidiasis is responsible for ∼ 10% of nosocomial sepsis in very-low-birth-weight infants and is associated with substantial morbidity and mortality. Over the last two decades, the antifungal armamentarium against Candida spp. has i ... Full text Link to item Cite

Lessons learned in pediatric clinical research to evaluate safe and effective use of drugs in pregnancy.

Journal Article Obstet Gynecol · April 2015 Children and pregnant women are vulnerable populations lacking clinical data to guide drug dosing. For children, over the past 15 years, the knowledge gap in pharmacokinetic, safety, and efficacy data has been narrowed as a result of the use of innovative ... Full text Link to item Cite

No survival benefit with empirical vancomycin therapy for coagulase-negative staphylococcal bloodstream infections in infants.

Journal Article Pediatr Infect Dis J · April 2015 BACKGROUND: Coagulase-negative Staphylococcus (CoNS) is the most common cause of bloodstream infections (BSI) in hospitalized infants. CoNS BSI is most reliably treated with vancomycin; however, concerns about side effects and promoting resistance often de ... Full text Link to item Cite

Bacterial meningitis in infants.

Journal Article Clin Perinatol · March 2015 Neonatal bacterial meningitis is uncommon but devastating. Morbidity among survivors remains high. The types and distribution of pathogens are related to gestational age, postnatal age, and geographic region. Confirming the diagnosis is difficult. Clinical ... Full text Link to item Cite

ANTIFUNGAL EXTRACTION BY THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT EX VIVO.

Conference CLINICAL PHARMACOLOGY & THERAPEUTICS · February 1, 2015 Link to item Cite

Safety of milrinone use in neonatal intensive care units.

Journal Article Early Hum Dev · January 2015 BACKGROUND: Milrinone use in the neonatal intensive care unit has increased over the last 10 years despite a paucity of published safety data in infants. We sought to determine the safety of milrinone therapy among infants in the neonatal intensive care un ... Full text Link to item Cite

Anaerobic antimicrobial therapy after necrotizing enterocolitis in VLBW infants.

Journal Article Pediatrics · January 2015 OBJECTIVE: To evaluate the effect of anaerobic antimicrobial therapy for necrotizing enterocolitis (NEC) on clinical outcomes in very low birth weight (≤1500 g) infants. METHODS: We identified very low birth weight infants with NEC from 348 US NICUs from 1 ... Full text Link to item Cite

Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots.

Journal Article Bioanalysis · 2015 BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed in children and adults. The study objectives were to validate and apply an HPLC-MS/MS method to quantify TMP-SMX in dried plasma spots (DPS) and dr ... Full text Link to item Cite

Vancomycin cerebrospinal fluid pharmacokinetics in children with cerebral ventricular shunt infections.

Journal Article Pediatr Infect Dis J · October 2014 This study described the cerebrospinal fluid (CSF) exposure of vancomycin in 8 children prescribed intravenous vancomycin therapy for cerebral ventricular shunt infection. Vancomycin CSF concentrations ranged from 0.06 to 9.13 mg/L and the CSF: plasma rati ... Full text Link to item Cite

Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents.

Journal Article Clin Pharmacol Ther · October 2014 Clindamycin is commonly prescribed to treat children with skin and skin-structure infections (including those caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA)), yet little is known about its pharmacokinetics (PK) across pe ... Full text Link to item Cite

Predictive performance of a gentamicin population pharmacokinetic model in neonates receiving full-body hypothermia.

Journal Article Ther Drug Monit · October 2014 BACKGROUND: Population pharmacokinetic (popPK) models derived from small pharmacokinetics (PK) studies in neonates are often underpowered to detect clinically important characteristics that drive dosing. External validation of such models is crucial. In th ... Full text Link to item Cite

Late-onset bloodstream infections in hospitalized term infants.

Journal Article Pediatr Infect Dis J · September 2014 BACKGROUND: The epidemiology and incidence of late-onset blood stream infections (BSIs) in premature infants have been described, but studies describing late-onset BSI in term infants are sparse. We sought to describe the pathogens, incidence, risk factors ... Full text Link to item Cite

A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.

Journal Article J Perinatol · September 2014 OBJECTIVE: Bronchopulmonary dysplasia (BPD) is the most common cause of pulmonary morbidity in premature infants and is associated with life-long morbidities. Developing drugs for the prevention of BPD would improve public health. We sought to determine ch ... Full text Link to item Cite

Advances in pediatric pharmacology, therapeutics, and toxicology.

Journal Article Adv Pediatr · August 2014 In the United States, passage of the FDASIA legislation made BPCA and PREA permanent, no longer requiring reauthorization every 5 years. This landmark legislation also stressed the importance of performing clinical trials in neonates when appropriate. In E ... Full text Link to item Cite

Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.

Journal Article Antimicrob Agents Chemother · June 2014 Although ampicillin is the most commonly used drug in neonates, developmental pharmacokinetic (PK) data to guide dosing are lacking. Ampicillin is primarily renally eliminated, and developmental changes are expected to influence PK. We conducted an open-la ... Full text Link to item Cite

Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.

Journal Article Drugs · June 2014 Invasive fungal disease (IFD) remains life threatening in premature infants and immunocompromised children despite the recent development of new antifungal agents. Optimal dosing of antifungals is one of the few factors clinicians can control to improve ou ... Full text Link to item Cite

Developmental pharmacokinetics of piperacillin and tazobactam using plasma and dried blood spots from infants.

Journal Article Antimicrob Agents Chemother · May 2014 Piperacillin-tazobactam is often given to infants with severe infection in spite of limited pharmacokinetics (PK) data. We evaluated piperacillin-tazobactam PK in premature and term infants of ages <61 days with suspected systemic infection. Infants receiv ... Full text Link to item Cite

Pharmacokinetics and safety of recently approved drugs used to treat methicillin-resistant Staphylococcus aureus infections in infants, children and adults.

Journal Article Expert Rev Clin Pharmacol · May 2014 Methicillin-resistant Staphylococcus aureus (MRSA) remains a significant cause of morbidity in hospitalized infants. Over the past 15 years, several drugs have been approved for the treatment of S. aureus infections in adults (linezolid, quinupristin/dalfo ... Full text Link to item Cite

Thromboprophylaxis with fondaparinux in high-risk postoperative patients with renal insufficiency.

Journal Article Thromb Res · April 2014 Fondaparinux is an antithrombin-dependent factor Xa inhibitor that is used for thromboprophylaxis of patients undergoing hip fracture surgery, hip or knee replacement, or abdominal surgery. It is cleared by the kidney and should be used with caution in pat ... Full text Link to item Cite

Predictors of positive cerebrospinal fluid cultures in infants with bacteremia.

Journal Article Pediatr Infect Dis J · April 2014 BACKGROUND: Meningitis causes substantial morbidity and mortality in hospitalized infants. There is no consensus on the ability of blood cultures to predict results from cerebrospinal fluid (CSF) cultures in hospitalized infants. METHODS: We used the Pedia ... Full text Link to item Cite

Drug labeling and exposure in neonates.

Journal Article JAMA Pediatr · February 2014 IMPORTANCE: Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insuffi ... Full text Link to item Cite

Population pharmacokinetics of intravenous acyclovir in preterm and term infants.

Journal Article Pediatr Infect Dis J · January 2014 BACKGROUND: Acyclovir is used to treat herpes infections in preterm and term infants; however, the influence of maturation on drug disposition and dosing requirements is poorly characterized in this population. METHODS: We administered intravenous acyclovi ... Full text Link to item Cite

Pharmacokinetic studies in infants using minimal-risk study designs.

Journal Article Curr Clin Pharmacol · 2014 Infants are therapeutic orphans. Many drugs used in infants are used "off-label", increasing the risk of drug toxicity and suboptimal efficacy in this vulnerable population. This knowledge gap in clinical pharmacology is partly attributed to challenges ass ... Full text Link to item Cite

Intestinal fatty-acid binding protein and metronidazole response in premature infants.

Journal Article J Neonatal Perinatal Med · January 1, 2014 OBJECTIVES: In premature infants with suspected intra-abdominal infection, biomarkers for treatment response to antimicrobial therapy are lacking. Intestinal fatty acid-binding protein (I-FABP) is specific to the enterocyte and is released in response to i ... Full text Link to item Cite

Sildenafil exposure and hemodynamic effect after Fontan surgery.

Journal Article Pediatr Crit Care Med · January 2014 OBJECTIVE: Determine sildenafil exposure and hemodynamic effect in children after Fontan single-ventricle surgery. DESIGN: Prospective dose-escalation trial. SETTING: Single-center pediatric catheterization laboratory. PATIENTS: Nine children post Fontan s ... Full text Link to item Cite

Population Pharmacokinetics of Intravenous Acyclovir in Preterm and Term Infants.

Journal Article Pediatr Infect Dis J · September 23, 2013 Acyclovir is used to treat herpes infections in preterm and term infants; however, the influence of maturation on drug disposition and dosing requirements is poorly characterized in this population. ... Full text Link to item Cite

Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.

Journal Article Pediatr Infect Dis J · September 2013 BACKGROUND: Limited pharmacokinetic (PK) data of metronidazole in premature infants have led to various dosing recommendations. Surrogate efficacy targets for metronidazole are ill-defined and therefore aimed to exceed minimum inhibitory concentration of o ... Full text Link to item Cite

The role of human cytochrome P450 enzymes in the formation of 2-hydroxymetronidazole: CYP2A6 is the high affinity (low Km) catalyst.

Journal Article Drug Metab Dispos · September 2013 Despite metronidazole's widespread clinical use since the 1960s, the specific enzymes involved in its biotransformation have not been previously identified. Hence, in vitro studies were conducted to identify and characterize the cytochrome P450 enzymes inv ... Full text Link to item Cite

Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.

Journal Article Pediatr Infect Dis J · July 2013 BACKGROUND: Carbapenems are commonly used in hospitalized infants despite a lack of complete safety data and associations with seizures in older children. We compared the incidence of adverse events in hospitalized infants receiving meropenem versus imipen ... Full text Link to item Cite

Sildenafil exposure and hemodynamic effect after stage II single-ventricle surgery.

Journal Article Pediatr Crit Care Med · July 2013 OBJECTIVES: To determine sildenafil exposure and hemodynamic effect in children after stage II single-ventricle surgery. DESIGN: Prospective, dose escalation trial. SETTING: Single-center, pediatric catheterization laboratory. PATIENTS: Twelve children pos ... Full text Link to item Cite

Antifungal agents and therapy for infants and children with invasive fungal infections: a pharmacological perspective.

Journal Article Br J Clin Pharmacol · June 2013 Invasive fungal infections, although relatively rare, are life-threatening diseases in premature infants and immunocompromised children. While many advances have been made in antifungal therapeutics in the last two decades, knowledge of the pharmacokinetic ... Full text Link to item Cite

Urinary tract infection concordance with positive blood and cerebrospinal fluid cultures in the neonatal intensive care unit.

Journal Article J Perinatol · April 2013 OBJECTIVE: Urinary tract infections (UTI) are common in the neonatal intensive care unit (NICU). Blood, urine and cerebrospinal fluid (CSF) cultures are frequently obtained to evaluate for infection. We sought to determine the concordance between positive ... Full text Link to item Cite

Risk factors for invasive candidiasis in infants >1500 g birth weight.

Journal Article Pediatr Infect Dis J · March 2013 BACKGROUND: We describe the incidence, risk factors and outcomes of invasive candidiasis in infants >1500 g birth weight. METHODS: We conducted a retrospective cohort study of infants >1500 g birth weight discharged from 305 neonatal intensive care units i ... Full text Link to item Cite

Group B Streptococcus and Escherichia coli infections in the intensive care nursery in the era of intrapartum antibiotic prophylaxis.

Journal Article Pediatr Infect Dis J · March 2013 BACKGROUND: Group B Streptococcus (GBS) and Escherichia coli cause serious bacterial infections (SBIs) and are associated with morbidity and mortality in newborn infants. Intrapartum antibiotic prophylaxis reduces early-onset SBIs caused by GBS. The effect ... Full text Link to item Cite

Triazole use in the nursery: fluconazole, voriconazole, posaconazole, and ravuconazole.

Journal Article Curr Drug Metab · February 2013 Invasive fungal infections in infants admitted to the neonatal intensive care unit are common and often fatal. The mainstay of therapy against invasive fungal infections is antifungal agents. Over the last two decades, the development and approval of these ... Link to item Cite

Echinocandins for the nursery: an update.

Journal Article Curr Drug Metab · February 2013 As the incidence rates of neonatal invasive fungal infection (IFI) have been increasing over the last years, research efforts have been addressed towards identifying both effective preventative strategies, and efficacious and well-tolerated antifungal drug ... Link to item Cite

Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants

Journal Article Pediatric Infectious Disease Journal · January 1, 2013 Background: Limited pharmacokinetic (PK) data of metronidazole in premature infants have led to various dosing recommendations. Surrogate efficacy targets for metronidazole are ill-defined and therefore aimed to exceed minimum inhibitory concentration of o ... Full text Cite

Pharmacokinetics of Antimicrobials in Obese Children.

Journal Article GaBI J · 2013 INTRODUCTION: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiologic changes associated with childhood obesity can alter antibiotic pharmacokinetics and o ... Full text Link to item Cite

Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.

Journal Article Clin Infect Dis · December 2012 BACKGROUND: Intra-abdominal infections are common in young infants and lead to significant morbidity and mortality. Meropenem is a broad-spectrum antimicrobial with excellent activity against pathogens associated with intra-abdominal infections. The purpos ... Full text Link to item Cite

Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation.

Journal Article Pediatr Infect Dis J · October 2012 BACKGROUND: Candida infections are a leading cause of infectious disease-related death in infants supported with extracorporeal membrane oxygenation (ECMO). The ECMO circuit can alter drug pharmacokinetics; thus, standard fluconazole dosing in children on ... Full text Link to item Cite

Pharmacokinetics and tolerability of single-dose daptomycin in young infants.

Journal Article Pediatr Infect Dis J · September 2012 Featured Publication BACKGROUND: Daptomycin is approved for the treatment of complicated skin and skin-structure infections and Staphylococcus aureus bacteremia. We sought to characterize daptomycin single-dose pharmacokinetics and tolerability in young infants. METHODS: Subje ... Full text Link to item Cite

Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health.

Journal Article Expert Rev Clin Pharmacol · September 2012 Clinical trials in children are challenging and filled with important ethical considerations that differ from adults. Given difficulties associated with pediatric clinical trials, off-label prescribing is a common practice in pediatrics, which can lead to ... Full text Link to item Cite

Use of the complete blood cell count in early-onset neonatal sepsis.

Journal Article Pediatr Infect Dis J · August 2012 BACKGROUND: Early-onset sepsis (EOS) is an important cause of morbidity and mortality in neonates, and its diagnosis remains challenging. The complete blood cell count and differential have been previously evaluated as diagnostic tools for EOS in small, si ... Full text Link to item Cite

Use of the complete blood cell count in late-onset neonatal sepsis.

Journal Article Pediatr Infect Dis J · August 2012 BACKGROUND: Late-onset sepsis is an important cause of morbidity and mortality in infants. Diagnosis of late-onset sepsis can be challenging. The complete blood cell count and differential have been previously evaluated as diagnostic tools for late-onset s ... Full text Link to item Cite

Therapeutic monitoring of voriconazole in children less than three years of age: a case report and summary of voriconazole concentrations for ten children.

Journal Article Pediatr Infect Dis J · June 2012 Voriconazole is the treatment of choice for invasive aspergillosis and its use is increasing in pediatrics. Minimal pharmacokinetic data exist in young children. We report voriconazole concentrations for 10 children <3 years of age and pharmacokinetic para ... Full text Link to item Cite

Population pharmacokinetics of piperacillin using scavenged samples from preterm infants.

Journal Article Ther Drug Monit · June 2012 Featured Publication OBJECTIVES: Piperacillin is often used in preterm infants for intra-abdominal infections; however, dosing has been derived from small single-center studies excluding extremely preterm infants at a highest risk for these infections. We evaluated the populat ... Full text Link to item Cite

Neonatal fungal infections: when to treat?

Journal Article Early Hum Dev · May 2012 Candida infections are a major cause of morbidity and mortality in neonatal intensive care units. Mortality following Candida bloodstream infections is as high as 40%, and neurodevelopmental impairment is common among survivors. Because invasive fungal inf ... Full text Link to item Cite

Antifungal therapy and outcomes in infants with invasive Candida infections.

Journal Article Pediatr Infect Dis J · May 2012 BACKGROUND: Invasive candidiasis is a leading cause of mortality and morbidity in neonatal intensive care units. Treatment recommendations are limited by a lack of comparative outcomes data. METHODS: We identified all infants ≤ 120 days of age with positiv ... Full text Link to item Cite

Clinical characteristics and response to prophylactic fluconazole of preterm VLBW neonates with baseline and acquired fungal colonisation in NICU: data from a multicentre RCT.

Journal Article Early Hum Dev · May 2012 BACKGROUND: Fungal colonisation by Candida spp. affects a high proportion of VLBW neonates in NICU. However, few data are available on the clinical characteristics of colonisation in preterm infants who are colonised at baseline via vertical transmission, ... Full text Link to item Cite

Early and late onset sepsis in very-low-birth-weight infants from a large group of neonatal intensive care units.

Journal Article Early Hum Dev · May 2012 BACKGROUND: Very-low-birth-weight (VLBW, <1500 g birth weight) infants are at high risk for both early- and late-onset sepsis. Prior studies have observed a predominance of Gram-negative organisms as a cause of early-onset sepsis and Gram-positive organism ... Full text Link to item Cite

Sepsis in young infants with congenital heart disease.

Journal Article Early Hum Dev · May 2012 BACKGROUND: We sought to describe the incidence, pathogen distribution, and mortality associated with blood culture-proven sepsis in young infants with congenital heart disease (CHD) admitted to a neonatal intensive care unit (NICU). METHODS: Cohort study ... Full text Link to item Cite

Very late onset infections in the neonatal intensive care unit.

Journal Article Early Hum Dev · April 2012 OBJECTIVE: We sought to determine the risk factors, incidence, and mortality of very late onset bacterial infection (blood, urine, or cerebrospinal fluid culture positive occurring after day of life 120) in preterm infants. STUDY DESIGN: A retrospective ob ... Full text Link to item Cite

Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants.

Journal Article Antimicrob Agents Chemother · April 2012 Featured Publication Pharmacokinetic (PK) studies in preterm infants are rarely conducted due to the research challenges posed by this population. To overcome these challenges, minimal-risk methods such as scavenged sampling can be used to evaluate the PK of commonly used drug ... Full text Link to item Cite

Pharmacokinetics of moxifloxacin in an infant with Mycoplasma hominis meningitis.

Journal Article Pediatr Infect Dis J · February 2012 Treatment of Mycoplasma hominis meningitis in infants is limited by a lack of consensus regarding therapy and limited pharmacokinetic data for agents to which M. hominis is susceptible. We report the successful treatment of a premature infant suffering fro ... Full text Link to item Cite

Anidulafungin for neonatal hematogenous Candida meningoencephalitis: identification of candidate regimens for humans using a translational pharmacological approach.

Journal Article Antimicrob Agents Chemother · February 2012 Hematogenous Candida meningoencephalitis (HCME) is a serious infection in premature neonates. Anidulafungin is an echinocandin antifungal agent with potent activity against Candida spp., but its efficacy and optimal regimens for human neonates with HCME ar ... Full text Link to item Cite

Fluconazole pharmacokinetics and safety in premature infants.

Journal Article Curr Med Chem · 2012 Invasive candidiasis (IC) in the premature infant population is a common infection that results in substantial morbidity and mortality. For these patients, fluconazole is among the first line therapies to treat and prevent IC, and yet few prospective studi ... Full text Link to item Cite

Development of a liquid chromatography-tandem mass spectrometry assay of six antimicrobials in plasma for pharmacokinetic studies in premature infants.

Journal Article J Chromatogr B Analyt Technol Biomed Life Sci · November 15, 2011 Featured Publication This method provides a simple extraction procedure, as well as a validated, sensitive, and specific liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of ampicillin, piperacillin, tazobactam, meropenem, acyclovir, and ... Full text Link to item Cite

Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections.

Journal Article Pediatr Infect Dis J · October 2011 Featured Publication BACKGROUND: Suspected or complicated intra-abdominal infections are common in young infants and lead to significant morbidity and mortality. Meropenem is a broad-spectrum antimicrobial agent with excellent activity against pathogens associated with intra-a ... Full text Link to item Cite

Innovative clinical trial design for pediatric therapeutics.

Journal Article Expert Rev Clin Pharmacol · September 2011 Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, althoug ... Full text Link to item Cite

Pediatric cardiovascular drug dosing in critically ill children and extracorporeal membrane oxygenation.

Journal Article J Cardiovasc Pharmacol · August 2011 Cardiovascular disease in children is common and results in significant morbidity and mortality. The sickest children with cardiovascular disease may require support with extracorporeal membrane oxygenation (ECMO), which provides life-saving assistance for ... Full text Link to item Cite

Pediatric cardiovascular drug trials, lessons learned.

Journal Article J Cardiovasc Pharmacol · July 2011 Few drugs have been labeled for pediatric cardiovascular indications, and many children with cardiac disease are prescribed drugs off-label. Recent initiatives have narrowed this gap, and as a result, there are an increasing number of cardiology trials in ... Full text Link to item Cite

Coagulase-negative staphylococcal infections in the neonatal intensive care unit.

Journal Article Infect Control Hosp Epidemiol · July 2011 BACKGROUND: Coagulase-negative staphylococci (CoNS) are the most commonly isolated pathogens in the neonatal intensive care unit (NICU). CoNS infections are associated with increased morbidity, including neurodevelopmental impairment. OBJECTIVE: To describ ... Full text Link to item Cite

Repeat lumbar punctures in infants with meningitis in the neonatal intensive care unit.

Journal Article J Perinatol · June 2011 Featured Publication OBJECTIVE: The purpose of this study is to examine the results of repeat lumbar puncture in infants with initial positive cerebrospinal fluid (CSF) cultures in order to determine the clinical characteristics and outcomes of infants with repeat positive cul ... Full text Link to item Cite

Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates.

Journal Article Clin Pharmacol Ther · May 2011 Featured Publication Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to de ... Full text Link to item Cite

Fluconazole loading dose pharmacokinetics and safety in infants.

Journal Article Pediatr Infect Dis J · May 2011 BACKGROUND: Invasive candidiasis is a leading cause of morbidity and mortality in critically ill infants. Prompt administration of fluconazole and achievement of the therapeutic target (area under the curve 0 to 24 hours >400 mg*h/L) improve outcomes in ca ... Full text Link to item Cite

Pharmacokinetics of antifungal agents in children.

Journal Article Early Hum Dev · March 2011 Invasive fungal infections in immunocompromised children are common and often fatal. The first antifungal agents such as amphotericin B and fluconazole offered effective treatment, but their use was often limited by toxicity and resistance. Numerous new an ... Full text Link to item Cite

Population pharmacokinetics of micafungin in neonates and young infants.

Journal Article Antimicrob Agents Chemother · June 2010 Featured Publication Micafungin is an echinocandin with potent activity against Candida spp. Hematogenous Candida meningoencephalitis (HCME) is a frequent complication of disseminated Candida infection in premature infants. A preclinical model of HCME suggests that micafungin ... Full text Link to item Cite

Outcomes of catheter-associated infections in pediatric patients with short bowel syndrome.

Journal Article J Pediatr Gastroenterol Nutr · April 2010 Featured Publication Children with short bowel syndrome requiring long-term total parenteral nutrition are at high risk for catheter-associated infections. The optimal management of catheter infections in this patient population is unknown. We conducted a retrospective observa ... Full text Link to item Cite

Recent Advances in the Detection of Neonatal Candidiasis.

Journal Article Curr Fungal Infect Rep · March 1, 2010 Neonatal candidiasis is serious and often fatal. Blood culture, the standard for diagnosis, has a sensitivity of 50% or less, and isolate speciation and susceptibility takes several days. This review explores recent advances in Candida detection using vari ... Full text Link to item Cite

Pediatric antifungal agents.

Journal Article Curr Opin Infect Dis · December 2009 PURPOSE OF REVIEW: In immunocompromised hosts, invasive fungal infections are common and fatal. In the past decade, the antifungal armamentarium against invasive mycoses has expanded greatly. The purpose of the present report is to review the most recent l ... Full text Link to item Cite

Clinical trial design in neonatal pharmacology: effect of center differences, with lessons from the Pediatric Oncology Cooperative Research experience.

Journal Article Clin Pharmacol Ther · December 2009 Survival for premature neonates has improved dramatically over the past 20 years; however, there has been minimal improvement in prematurity-associated morbidities. Morbidity rates and assessment of outcomes vary across neonatology intensive care units (NI ... Full text Link to item Cite

Early and late onset sepsis in late preterm infants.

Journal Article Pediatr Infect Dis J · December 2009 Featured Publication BACKGROUND: Preterm birth is increasing worldwide, and late preterm births, which comprise more than 70% of all preterm births, account for much of the increase. Early and late onset sepsis results in significant mortality in extremely preterm infants, but ... Full text Link to item Cite

Management of neonatal candidiasis

Journal Article Journal of Invasive Fungal Infections · December 1, 2009 Invasive candidiasis (IC) is common and often fatal in extremely premature neonates. In the last decade, the therapeutic armamentarium for IC has markedly expanded; however, the pharmacokinetics, safety and efficacy of most antifungal agents in premature n ... Cite

Immunotherapy in neonatal sepsis: advances in treatment and prophylaxis.

Journal Article Curr Opin Pediatr · April 2009 PURPOSE OF REVIEW: Systemic infections in premature and term infants cause significant morbidity and mortality in spite of appropriate antimicrobial therapy. Consequently, immunotherapy has emerged as a potential adjuvant therapeutic modality to reduce the ... Full text Link to item Cite

Daptomycin use in infants: report of two cases with peak and trough drug concentrations.

Journal Article J Perinatol · March 2008 We report two infants treated with daptomycin for methicillin-resistant Staphylococcus aureus infection and describe peak and trough blood concentrations measured during therapy. The peak concentrations were 41.7 and 36.7 mcg ml(-1), and the 12-hour trough ... Full text Link to item Cite

Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants.

Journal Article Pediatr Infect Dis J · December 2007 We compared outcomes in infants with methicillin-resistant and methicillin-sensitive Staphylococcus aureus bacteremia. Infants with methicillin-resistant S. aureus infection had a longer median duration of bacteremia (4.5 versus 1 day, P = 0.01), but no di ... Full text Link to item Cite

Neonatal Candida meningitis: significance of cerebrospinal fluid parameters and blood cultures.

Journal Article J Perinatol · February 2007 OBJECTIVE: The purpose of this study was to examine the frequency of normal cerebrospinal fluid (CSF) parameters in Candida meningitis and the proportion of candidemia associated with Candida meningitis. STUDY DESIGN: We evaluated the initial lumbar punctu ... Full text Link to item Cite

Anidulafungin: a new echinocandin for the treatment of fungal infections.

Journal Article Drugs Today (Barc) · August 2006 Immunocompromised hosts are at increased risk for invasive fungal infections. Over the last five decades, the mainstay of therapy against systemic mycoses has revolved around amphotericin B deoxycholate. Unfortunately, this drug has substantial toxicities, ... Full text Link to item Cite

Intra-arterial microdosing (IAM), a novel drug development approach, proof-of-concept in rodents

Conference American College of Clinical Pharmacology (ACCP) 2015 Annual Meeting. Cite