Scholars@Duke
Thomas Lawrence Holland

Thomas Lawrence Holland

Professor of Medicine
Medicine, Infectious Diseases
Duke Box 102359, Durham, NC 27710
Room 163 Hanes House, Trent Drive, Durham, NC 27710

Scholarly Works - Journal articles

Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections.

Journal article Open Forum Infect Dis · June 2026 BACKGROUND: Desirability of outcome ranking (DOOR), a paradigm for the design, analysis, and interpretation of clinical trials based on patient-centered benefit-risk evaluation, could help inform drug development for acute bacterial skin and skin structure ... Full text Link to item Cite

Timing of Bronchoscopy and Plasma Microbial Cell-Free DNA Sequencing in Immunocompromised Host Pneumonia.

Journal article Open Forum Infect Dis · June 2026 BACKGROUND: Immunocompromised patients are at high risk of pneumonia, with associated poor outcomes. Rapid microbiologic diagnosis is crucial, yet diagnostic yields vary widely. We evaluated the variability in diagnostic yield of usual care testing and pla ... Full text Link to item Cite

Pharmacokinetics of Dalbavancin in Complicated Staphylococcus aureus Bacteremia: A Secondary Analysis of the DOTS Randomized Clinical Trial.

Journal article JAMA Netw Open · April 1, 2026 IMPORTANCE: Dalbavancin is an alternative to prolonged intravenous therapy for complicated Staphylococcus aureus bacteremia, yet its pharmacokinetics (PK) in patients with this condition are uncertain. OBJECTIVE: To characterize dalbavancin PK and evaluate ... Full text Open Access Link to item Cite

A patient-centric paradigm and tool for clinical research: the DOOR is open.

Journal article Antimicrob Agents Chemother · January 7, 2026 Randomized clinical trials are the gold standard for evaluating the benefits and harms of interventions and yet may not provide the evidence needed to inform medical decision-making, an ultimate goal for clinical research. Commonly used design and analysis ... Full text Link to item Cite

Management of Staphylococcus aureus Bacteremia: A Review.

Journal article JAMA · September 2, 2025 IMPORTANCE: Staphylococcus aureus, a gram-positive bacterium, is the leading cause of death from bacteremia worldwide, with a case fatality rate of 15% to 30% and an estimated 300 000 deaths per year. OBSERVATIONS: Staphylococcus aureus bacteremia causes m ... Full text Link to item Cite

Dalbavancin for Treatment of Staphylococcus aureus Bacteremia: The DOTS Randomized Clinical Trial.

Journal article JAMA · August 13, 2025 IMPORTANCE: Dalbavancin is a long-acting intravenous lipoglycopeptide that may be effective for treatment of complicated Staphylococcus aureus bacteremia without requiring long-term intravenous access. OBJECTIVE: To evaluate the efficacy and safety of dalb ... Full text Link to item Cite

A Qualitative Secondary Analysis of Patient Health-Related Quality of Life in Bloodstream Infections by Source: Intra-abdominal, Urinary Tract, and Acute Bacterial Skin and Skin Structure Infection.

Journal article Clin Infect Dis · August 6, 2025 BACKGROUND: Despite the prevalence of intra-abdominal infections, urinary tract infections, and skin/skin structure infections, the relative impact of these syndromes on patient health-related quality of life (HRQoL) is unclear. This qualitative secondary ... Full text Open Access Link to item Cite

Interagency Collaboration for Patient-Centered Antibacterial Drug Development.

Journal article Clin Infect Dis · August 6, 2025 This manuscript presents key advances of the Antibacterial Resistance Leadership Group (ARLG) Innovations Task Force, a collaboration focused on improving endpoints for registrational trials of antibacterial drugs, including health-related quality-of-life ... Full text Link to item Cite

A network analysis of carbapenem-resistant Klebsiella pneumoniae among healthcare facilities.

Journal article Sci Rep · July 29, 2025 With limited treatments for carbapenem-resistant Klebsiella pneumoniae (CRKp), curtailing transmission is critical. We applied a network analysis using epidemiological admission data and bacterial genetics to characterize CRKp spread among patients in 16 a ... Full text Link to item Cite

Passive immunotherapy for adults hospitalized with COVID-19: An individual participant data meta-analysis of six randomized controlled trials.

Journal article PLoS Med · July 2025 BACKGROUND: Anti-SARS-CoV-2 monoclonal antibodies (mAb) reduce the risk of hospitalization in outpatients with mild-to-moderate COVID-19. However, the efficacy of treatment with mAbs and other passive immunotherapies in patients hospitalized with severe CO ... Full text Link to item Cite

Impact of obesity on clinical outcomes in patients treated with ceftobiprole: results from Phase 3 clinical trials.

Journal article J Antimicrob Chemother · June 3, 2025 BACKGROUND: Ceftobiprole was non-inferior to comparators for the treatment of Staphylococcus aureus bloodstream infection (bacteraemia) (SAB), acute bacterial skin and skin structure infection (ABSSSI), and community-acquired bacterial pneumonia (CABP), le ... Full text Link to item Cite

Long-term outcomes of passive immunotherapy for COVID-19: a pooled analysis of a large multinational platform randomized clinical trial.

Journal article Clin Microbiol Infect · June 2025 OBJECTIVES: Passive immunotherapy, including monoclonal antibodies and neutralizing proteins, was used for the treatment of patients with COVID-19 during the pandemic. Accelerating COVID-19 Therapeutic Interventions and Vaccines-Therapeutics for Inpatients ... Full text Link to item Cite

Combination therapy with fosfomycin for Staphylococcus aureus bacteraemia or endocarditis: a systematic review and meta-analysis of randomized trials.

Journal article JAC Antimicrob Resist · June 2025 BACKGROUND AND OBJECTIVES: Fosfomycin combination therapy for Staphylococcus aureus bacteraemia or endocarditis has been evaluated, but studies were limited by small sample sizes. We sought to conduct a systematic review and meta-analysis of randomized con ... Full text Link to item Cite

SARS-Cov-2 vaccination strategies in hospitalized recovered COVID-19 patients: a randomized clinical trial (VATICO Trial).

Journal article Sci Rep · March 22, 2025 The impact on immunogenicity and efficacy of SARS-CoV-2 vaccination in people with prior COVID-19 could differ depending on timing of vaccination and number of doses. The VATICO study randomized 66 hospitalized recovered COVID-19 individuals to receive eit ... Full text Link to item Cite

Oral Versus Intravenous Antibiotic Therapy for Staphylococcus aureus Bacteremia or Endocarditis: A Systematic Review and Meta-Analysis of Randomized, Controlled Trials.

Journal article Clin Infect Dis · February 5, 2025 BACKGROUND: We conducted a systematic review of randomized, controlled trials (RCTs) to generate more precise estimates of the efficacy and safety of oral versus intravenous antibiotic therapy for Staphylococcus aureus bacteremia or endocarditis. METHODS: ... Full text Link to item Cite

Impact of an Algorithm to Triage Patients Discharged From the Emergency Department With Blood Cultures Positive for Staphylococcus aureus or Coagulase-Negative Staphylococcus.

Journal article J Am Coll Emerg Physicians Open · February 2025 OBJECTIVES: Blood cultures obtained in the emergency department (ED) may become positive after discharge. Healthcare professionals must determine if these results represent true infection or a likely contaminant. An institutional algorithm was developed to ... Full text Link to item Cite

Long-term anti-SARS-CoV-2 antibody trajectories after neutralizing monoclonal antibody treatment.

Journal article PLoS One · 2025 BACKGROUND: Neutralizing monoclonal antibodies (nMAbs) have been used to treat COVID-19 and are increasingly being used to treat other infections. However, there is concern that by neutralizing the SARS-CoV-2 virus, nMAbs may decrease the availability of a ... Full text Link to item Cite

Increased mortality in hospital- compared to community-onset carbapenem-resistant enterobacterales infections.

Journal article J Antimicrob Chemother · November 4, 2024 BACKGROUND: The CDC reported a 35% increase in hospital-onset (HO) carbapenem-resistant Enterobacterales (CRE) infections during the COVID-19 pandemic. We evaluated patient outcomes following HO and community-onset (CO) CRE bloodstream infections (BSI). ME ... Full text Link to item Cite

Cost-Effectiveness of Plasma Microbial Cell-Free DNA Sequencing When Added to Usual Care Diagnostic Testing for Immunocompromised Host Pneumonia.

Journal article Pharmacoeconomics · September 2024 INTRODUCTION: Immunocompromised host pneumonia (ICHP) is an important cause of morbidity and mortality, yet usual care (UC) diagnostic tests often fail to identify an infectious etiology. A US-based, multicenter study (PICKUP) among ICHP patients with hema ... Full text Link to item Cite

Clinical Utility of Plasma Microbial Cell-Free DNA Sequencing Among Immunocompromised Patients With Pneumonia.

Journal article Open Forum Infect Dis · August 2024 BACKGROUND: Plasma microbial cell-free DNA (mcfDNA) sequencing can establish the etiology of multiple infectious syndromes by identifying microbial DNA in plasma. However, data are needed to define the clinical scenarios where this tool offers the highest ... Full text Link to item Cite

Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs.

Journal article Clin Infect Dis · July 19, 2024 BACKGROUND: Desirability of outcome ranking (DOOR) is an innovative approach to clinical trial design and analysis that uses an ordinal ranking system to incorporate the overall risks and benefits of a therapeutic intervention into a single measurement. He ... Full text Link to item Cite

Clinical outcomes in patients with piperacillin/tazobactam-non-susceptible but ceftriaxone-susceptible E. coli or K. pneumoniae bloodstream infection.

Journal article J Antimicrob Chemother · June 3, 2024 BACKGROUND: A small proportion of Escherichia coli and Klebsiella pneumoniae demonstrate in vitro non-susceptibility to piperacillin/tazobactam but retain susceptibility to ceftriaxone. Uncertainty remains regarding how best to treat these isolates. OBJECT ... Full text Link to item Cite

Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study

Journal article Lancet Microbe · June 1, 2024 Background: Serial measurement of virological and immunological biomarkers in patients admitted to hospital with COVID-19 can give valuable insight into the pathogenic roles of viral replication and immune dysregulation. We aimed to characterise biomarker ... Full text Cite

External Validation of the 2023 Duke-International Society for Cardiovascular Infectious Diseases Diagnostic Criteria for Infective Endocarditis.

Journal article Clin Infect Dis · April 10, 2024 BACKGROUND: The 2023 Duke-International Society of Cardiovascular Infectious Diseases (ISCVID) criteria for infective endocarditis (IE) were introduced to improve classification of IE for research and clinical purposes. External validation studies are requ ... Full text Link to item Cite

Plasma Microbial Cell-Free DNA Sequencing in Immunocompromised Patients With Pneumonia: A Prospective Observational Study.

Journal article Clin Infect Dis · March 20, 2024 BACKGROUND: Pneumonia is a common cause of morbidity and mortality, yet a causative pathogen is identified in a minority of cases. Plasma microbial cell-free DNA sequencing may improve diagnostic yield in immunocompromised patients with pneumonia. METHODS: ... Full text Link to item Cite

Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials

Journal article Eclinicalmedicine · March 1, 2024 Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup of p ... Full text Cite

Moving Beyond Mortality: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.

Journal article Clin Infect Dis · February 17, 2024 BACKGROUND: Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) are frequently caused by multidrug-resistant organisms. Patient-centered endpoints in clinical trials are needed to develop new antibiotics for HABP/VABP. Desirability ... Full text Link to item Cite

Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials.

Journal article J Clin Transl Sci · 2024 The emergence of the COVID-19 pandemic required an immediate global clinical research response. The ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)-3 trials and the ACTIV-associated Outpatient Treatment with Anti-Coronavirus Immunoglob ... Full text Link to item Cite

Ceftobiprole for Staphylococcus aureus Bacteremia REPLY

Journal article NEW ENGLAND JOURNAL OF MEDICINE · December 28, 2023 Link to item Cite

Scoping review of percutaneous mechanical aspiration for valvular and cardiac implantable electronic device infective endocarditis.

Journal article Clin Microbiol Infect · December 2023 BACKGROUND: Percutaneous mechanical aspiration (PMA) of intravascular vegetations is a novel strategy for management of patients with infective endocarditis (IE) who are at high risk of poor outcomes with conventional cardiac surgery. However, clear indica ... Full text Link to item Cite

Correction: Epidemiological Changes and Improvement in Outcomes of Infective Endocarditis in Europe in the Twenty-First Century: An International Collaboration on Endocarditis (ICE) Prospective Cohort Study (2000–2012) (Infectious Diseases and Therapy, (2023), 12, 4, (1083-1101), 10.1007/s40121-023-00763-8)

Journal article Infectious Diseases and Therapy · December 1, 2023 In the original publication of the article, there was an error with the map presented in Fig. 1 and the Graphical Abstract. The correct version of Fig. 1 and the Graphical Abstract are given below. The original article has also been updated. (Figure presen ... Full text Cite

Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review.

Journal article Clin Infect Dis · October 16, 2023 The Antibacterial Resistance Leadership Group (ARLG) has prioritized infections caused by gram-positive bacteria as one of its core areas of emphasis. The ARLG Gram-positive Committee has focused on studies responding to 3 main identified research prioriti ... Full text Link to item Cite

Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia.

Journal article N Engl J Med · October 12, 2023 BACKGROUND: Ceftobiprole is a cephalosporin that may be effective for treating complicated Staphylococcus aureus bacteremia, including methicillin-resistant S. aureus. METHODS: In this phase 3, double-blind, double-dummy, noninferiority trial, adults with ... Full text Link to item Cite

Exploration of a Potential Desirability of Outcome Ranking Endpoint for Complicated Intra-Abdominal Infections Using 9 Registrational Trials for Antibacterial Drugs.

Journal article Clin Infect Dis · August 22, 2023 BACKGROUND: Desirability of outcome ranking (DOOR) is a novel approach to clinical trial design that incorporates safety and efficacy assessments into an ordinal ranking system to evaluate overall outcomes of clinical trial participants. Here, we derived a ... Full text Open Access Link to item Cite

Which trial do we need? Next-generation sequencing to individualize therapy in Staphylococcus aureus bacteraemia.

Journal article Clin Microbiol Infect · August 2023 We propose a two-stage clinical trial in patients with Staphylococcus aureus bacteremia (SAB). In Stage 1 we will evaluate metagenomic next generation sequencing from blood as a quantitative biological surrogate for clinical endpoint in patients with SAB, ... Full text Link to item Cite

Dexamethasone for Inpatients With COVID-19 in a National Cohort.

Journal article JAMA Netw Open · April 3, 2023 IMPORTANCE: Limited effective therapeutics are available to hospitalized patients with COVID-19. Clinical trials and observational studies have shown varying effects of systemic corticosteroids, including dexamethasone, in hospitalized patients with COVID- ... Full text Link to item Cite

Epidemiological Changes and Improvement in Outcomes of Infective Endocarditis in Europe in the Twenty-First Century: An International Collaboration on Endocarditis (ICE) Prospective Cohort Study (2000–2012)

Journal article Infectious Diseases and Therapy · April 1, 2023 Introduction: Infective endocarditis (IE) has undergone important changes in its epidemiology worldwide. Methods: The study aimed to compare IE epidemiological features and outcomes according to predefined European regions and between two different time pe ... Full text Cite

Improving Traditional Registrational Trial End Points: Development and Application of a Desirability of Outcome Ranking End Point for Complicated Urinary Tract Infection Clinical Trials.

Journal article Clin Infect Dis · February 8, 2023 BACKGROUND: Traditional end points used in registrational randomized, controlled trials (RCTs) often do not allow for complete interpretation of the full range of potential clinical outcomes. Desirability of outcome ranking (DOOR) is an approach to the des ... Full text Open Access Link to item Cite

Correction to Lancet Respir Med 2022; 10: 972–84

Journal article The Lancet Respiratory Medicine · December 2022 Full text Cite

Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial.

Journal article Crit Care · November 15, 2022 BACKGROUND: Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was ... Full text Open Access Link to item Cite

Persistent Methicilin-Resistant Staphylococcus aureus Bacteremia: Resetting the Clock for Optimal Management.

Journal article Clin Infect Dis · October 29, 2022 A positive follow-up blood culture for methicillin-resistant Staphylococcus aureus (MRSA) while on seemingly appropriate therapy is a common and ominous development. However, the definition and management of persistent MRSA bacteremia is unstandardized. In ... Full text Open Access Link to item Cite

Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial.

Journal article Lancet Respir Med · October 2022 BACKGROUND: Tixagevimab-cilgavimab is a neutralising monoclonal antibody combination hypothesised to improve outcomes for patients hospitalised with COVID-19. We aimed to compare tixagevimab-cilgavimab versus placebo, in patients receiving remdesivir and o ... Full text Open Access Link to item Cite

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Journal article Ann Intern Med · September 2022 BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care ... Full text Open Access Link to item Cite

PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts.

Journal article Open Forum Infect Dis · July 2022 BACKGROUND: The prospective identification of patients at high risk for hospital-acquired/ventilator-associated bacterial pneumonia may improve clinical trial feasibility and foster antibacterial development. In a prior study conducted in the United States ... Full text Open Access Link to item Cite

Determination of plasma protein binding of dalbavancin.

Journal article J Antimicrob Chemother · June 29, 2022 OBJECTIVES: Dalbavancin is a lipoglycopeptide with a long half-life, making it a promising treatment for infections requiring prolonged therapy, such as complicated Staphylococcus aureus bacteraemia. Free drug concentration is a critical consideration with ... Full text Open Access Link to item Cite

Antiplatelet Therapy in Staphylococcus aureus Bacteremia: No Time Like the Past?

Journal article Antimicrob Agents Chemother · June 21, 2022 In this invited commentary, we reflect on the accompanying study by A. R. Caffrey, H. J. Appaneal, K. L. LaPlante, V. V. Lopes, et al. (Antimicrob Agents Chemother 66:e02117-21, 2022, https://doi.org/10.1128/aac.02117-21), which analyzed the impact of clop ... Full text Open Access Link to item Cite

A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection.

Journal article Open Forum Infect Dis · June 2022 BACKGROUND: Although a short course (7 days) of antibiotics has been demonstrated to be noninferior to a conventional course (14 days) in terms of mortality and infectious complications for patients with a Gram-negative bacterial bloodstream infection (GNB ... Full text Open Access Link to item Cite

Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial.

Journal article Trials · May 16, 2022 BACKGROUND: Staphylococcus aureus bacteremia is a life-threatening infection and leading cause of infective endocarditis, with mortality rates of 15-50%. Treatment typically requires prolonged administration of parenteral therapy, itself associated with hi ... Full text Open Access Link to item Cite

Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial.

Journal article Lancet Infect Dis · May 2022 BACKGROUND: We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereaf ... Full text Link to item Cite

Severe Retiform Purpura Associated With COVID-19 Infection

Journal article Annals of Internal Medicine Clinical Cases · April 1, 2022 A healthy, unvaccinated 44-year-old woman developed a severe, diffusely spread, and intensely painful purpuric rash following mild COVID-19 infection. A punch skin biopsy revealed small vessel inflammation and intravascular thrombi consistent with thrombot ... Full text Cite

Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.

Journal article Ann Intern Med · February 2022 BACKGROUND: In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futilit ... Full text Link to item Cite

Associations Between Vancomycin Exposure and Acute Kidney Injury Within the Recommended Area Under the Curve Therapeutic Exposure Range Among Patients With Methicillin-Resistant Staphylococcus aureus Bloodstream Infections.

Journal article Open Forum Infect Dis · February 2022 Among patients with methicillin-resistant Staphylococcus aureus bacteremia, vancomycin-associated acute kidney injury increased as a function of the day 2 area under the curve (AUC), even for daily AUCs within the recommended therapeutic range (400-600). F ... Full text Link to item Cite

Patients' Experiences With Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life.

Journal article Open Forum Infect Dis · February 2022 BACKGROUND: We previously conducted a concept elicitation study on the impact of Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significa ... Full text Open Access Link to item Cite

Of Rats and Men: a Translational Model To Understand Vancomycin Pharmacokinetic/Toxicodynamic Relationships.

Journal article Antimicrob Agents Chemother · September 17, 2021 Vancomycin area under the concentration curve (AUC) is known to predict vancomycin-induced acute kidney injury (AKI). Data were analyzed from a rat model (n = 48) and two prospective clinical studies (PROVIDE [n = 263] and CAMERA2 [n = 291]). A logit-link ... Full text Link to item Cite

Antibacterial Resistance Leadership Group 2.0: Back to Business.

Journal article Clin Infect Dis · August 16, 2021 In December 2019, the Antibacterial Resistance Leadership Group (ARLG) was awarded funding for another 7-year cycle to support a clinical research network on antibacterial resistance. ARLG 2.0 has 3 overarching research priorities: infections caused by ant ... Full text Open Access Link to item Cite

Patients' Experiences With Staphylococcus aureus and Gram-negative Bacterial Bloodstream Infections: A Qualitative Descriptive Study and Concept Elicitation Phase To Inform Measurement of Patient-reported Quality of Life.

Journal article Clin Infect Dis · July 15, 2021 BACKGROUND: Although Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) cause substantial morbidity, little is known regarding patient perceptions' of their impact on quality of life (QOL). Guidance for assessing QOL and dis ... Full text Open Access Link to item Cite

Infective Endocarditis in Patients on Chronic Hemodialysis.

Journal article J Am Coll Cardiol · April 6, 2021 BACKGROUND: Infective endocarditis (IE) is a common and serious complication in patients receiving chronic hemodialysis (HD). OBJECTIVES: This study sought to investigate whether there are significant differences in complications, cardiac surgery, relapses ... Full text Link to item Cite

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.

Journal article N Engl J Med · March 11, 2021 BACKGROUND: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on ... Full text Link to item Cite

Evidence-Based Guidelines Should Be Used To Inform COVID-19 Management.

Journal article Antimicrob Agents Chemother · February 17, 2021 Full text Link to item Cite

Aspiration Risk Factors, Microbiology, and Empiric Antibiotics for Patients Hospitalized With Community-Acquired Pneumonia.

Journal article Chest · January 2021 BACKGROUND: Aspiration community-acquired pneumonia (ACAP) and community-acquired pneumonia (CAP) in patients with aspiration risk factors (AspRFs) are infections associated with anaerobes, but limited evidence suggests their pathogenic role. RESEARCH QUES ... Full text Open Access Link to item Cite

PROPHETIC: Prospective Identification of Pneumonia in Hospitalized Patients in the ICU.

Journal article Chest · December 2020 BACKGROUND: Pneumonia is the leading infection-related cause of death. The use of simple clinical criteria and contemporary epidemiology to identify patients at high risk of nosocomial pneumonia should enhance prevention efforts and facilitate development ... Full text Open Access Link to item Cite

Remdesivir for the Treatment of Covid-19 - Final Report.

Journal article N Engl J Med · November 5, 2020 BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS: We conducted a double-blind, randomized, placebo-controlled tr ... Full text Link to item Cite

Early Oral Antibiotic Switch for Staphylococcus aureus Bacteremia: Many Are Called, but Few Are Chosen.

Journal article Antimicrob Agents Chemother · June 23, 2020 Staphylococcus aureus bacteremia (SAB) is a complicated, high-risk disease. For selected low-risk SAB, the role of oral antibiotic stepdown therapy is unknown. Bupha-Intr et al. report a retrospective cohort of low-risk SAB patients who did well with a sho ... Full text Link to item Cite

Prevalence and risk factors for Enterobacteriaceae in patients hospitalized with community-acquired pneumonia.

Journal article Respirology · May 2020 BACKGROUND AND OBJECTIVE: Enterobacteriaceae (EB) spp. family is known to include potentially multidrug-resistant (MDR) microorganisms, and remains as an important cause of community-acquired pneumonia (CAP) associated with high mortality. The aim of this ... Full text Link to item Cite

Whole-genome sequencing of Staphylococcus epidermidis bloodstream isolates from a prospective clinical trial reveals that complicated bacteraemia is caused by a limited number of closely related sequence types.

Journal article Clin Microbiol Infect · May 2020 OBJECTIVES: The significance of isolating Staphylococus epidermidis from a blood culture is highly heterogeneous, ranging from contamination to an indication of a serious infection. Herein we sought to determine whether there is a relationship between S. e ... Full text Link to item Cite

Consensus on Language for Advance Informed Consent in Health Care-Associated Pneumonia Clinical Trials Using a Delphi Process.

Journal article JAMA Netw Open · May 1, 2020 IMPORTANCE: Information to be included in advance informed consent forms for health care-associated pneumonia treatment trials remains to be determined. OBJECTIVE: To identify and determine how to describe information to be included in an advance informed ... Full text Link to item Cite

The Emperor's New Clothes: PRospective Observational Evaluation of the Association Between Initial VancomycIn Exposure and Failure Rates Among ADult HospitalizEd Patients With Methicillin-resistant Staphylococcus aureus Bloodstream Infections (PROVIDE).

Journal article Clin Infect Dis · April 10, 2020 BACKGROUND: Vancomycin is the most commonly administered antibiotic in hospitalized patients, but optimal exposure targets remain controversial. To clarify the therapeutic exposure range, this study evaluated the association between vancomycin exposure and ... Full text Link to item Cite

A pooled analysis of patients with wound infections in the Phase 3 REVIVE trials: randomized, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin structure infections.

Journal article J Med Microbiol · April 2020 Introduction. Iclaprim is a diaminopyrimidine antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) due to Gram-positive pathogens.Aim. This analysis evaluates patients with wound infections from two Phase 3 trials of ... Full text Link to item Cite

Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial.

Journal article Future Microbiol · January 2020 Although Staphylococcus aureus is a common cause of bacteremia, treatment options are limited. The need for new therapies is particularly urgent for methicillin-resistant S. aureus bacteremia (SAB). Ceftobiprole is an advanced-generation, broad-spectrum ce ... Full text Link to item Cite

International prevalence and risk factors evaluation for drug-resistant Streptococcus pneumoniae pneumonia.

Journal article J Infect · October 2019 OBJECTIVE: Streptococcus pneumoniae is the most frequent bacterial pathogen isolated in subjects with Community-acquired pneumonia (CAP) worldwide. Limited data are available regarding the current global burden and risk factors associated with drug-resista ... Full text Open Access Link to item Cite

Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS).

Journal article Clin Infect Dis · May 17, 2019 Patient management is not based on a single decision. Rather, it is dynamic: based on a sequence of decisions, with therapeutic adjustments made over time. Adjustments are personalized: tailored to individual patients as new information becomes available. ... Full text Link to item Cite

Good Studies Evaluate the Disease While Great Studies Evaluate the Patient: Development and Application of a Desirability of Outcome Ranking Endpoint for Staphylococcus aureus Bloodstream Infection.

Journal article Clin Infect Dis · May 2, 2019 BACKGROUND: Desirability of outcome ranking (DOOR) is an innovative approach in clinical trials to evaluate the global benefits and risks of an intervention. We developed and validated a DOOR endpoint for Staphylococcus aureus bloodstream infection (BSI) t ... Full text Link to item Cite

Prevalence and Etiology of Community-acquired Pneumonia in Immunocompromised Patients.

Journal article Clin Infect Dis · April 24, 2019 BACKGROUND: The correct management of immunocompromised patients with pneumonia is debated. We evaluated the prevalence, risk factors, and characteristics of immunocompromised patients coming from the community with pneumonia. METHODS: We conducted a secon ... Full text Open Access Link to item Cite

Methicillin-resistant Staphylococcus aureus: an overview of basic and clinical research.

Journal article Nat Rev Microbiol · April 2019 Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most successful modern pathogens. The same organism that lives as a commensal and is transmitted in both health-care and community settings is also a leading cause of bacteraemia, endocarditi ... Full text Open Access Link to item Cite

Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.

Journal article Clin Infect Dis · February 15, 2019 Clinical trials for Staphylococcus aureus bloodstream infections (SAB) are broadly grouped into 2 categories: registrational trials intended to support regulatory approval of antibiotics for the treatment of SAB and strategy trials intended to inform clini ... Full text Link to item Cite

Surveillance of iclaprim activity: in vitro susceptibility of Gram-positive skin infection pathogens collected from 2015 to 2016 from North America and Europe.

Journal article Diagn Microbiol Infect Dis · February 2019 Iclaprim is a diaminopyrimidine, which inhibits bacterial dihydrofolate reductase, and surveillance data prior to 2006 suggested that iclaprim was active against Gram-positive pathogens including emerging drug-resistant pathogens. In an era of increasing a ... Full text Link to item Cite

An international perspective on hospitalized patients with viral community-acquired pneumonia.

Journal article Eur J Intern Med · February 2019 BACKGROUND: Who should be tested for viruses in patients with community acquired pneumonia (CAP), prevalence and risk factors for viral CAP are still debated. We evaluated the frequency of viral testing, virus prevalence, risk factors and treatment coverag ... Full text Open Access Link to item Cite

Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia.

Journal article JAMA Netw Open · December 7, 2018 IMPORTANCE: Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However ... Full text Link to item Cite

Microbiological testing of adults hospitalised with community-acquired pneumonia: an international study.

Journal article ERJ Open Res · October 2018 This study aimed to describe real-life microbiological testing of adults hospitalised with community-acquired pneumonia (CAP) and to assess concordance with the 2007 Infectious Diseases Society of America (IDSA)/American Thoracic Society (ATS) and 2011 Eur ... Full text Open Access Link to item Cite

Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial.

Journal article JAMA · September 25, 2018 IMPORTANCE: The appropriate duration of antibiotics for staphylococcal bacteremia is unknown. OBJECTIVE: To test whether an algorithm that defines treatment duration for staphylococcal bacteremia vs standard of care provides noninferior efficacy without in ... Full text Open Access Link to item Cite

Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections.

Journal article Int J Antimicrob Agents · August 2018 Iclaprim, a diaminopyrimidine antimicrobial, was compared with vancomycin for treatment of patients with acute bacterial skin and skin-structure infections (ABSSSIs) in two studies (REVIVE-1 and REVIVE-2). Here, the efficacy and tolerability of iclaprim in ... Full text Link to item Cite

Burden and risk factors for Pseudomonas aeruginosa community-acquired pneumonia: a multinational point prevalence study of hospitalised patients.

Journal article Eur Respir J · August 2018 Pseudomonas aeruginosa is a challenging bacterium to treat due to its intrinsic resistance to the antibiotics used most frequently in patients with community-acquired pneumonia (CAP). Data about the global burden and risk factors associated with P. aerugin ... Full text Open Access Link to item Cite

A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study).

Journal article Antimicrob Agents Chemother · May 2018 Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global phase 3, double-blind, randomized, active-controlled trial. Six hun ... Full text Link to item Cite

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1.

Journal article Clin Infect Dis · April 3, 2018 BACKGROUND: Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). METHODS: REVIVE-1 was a phase 3, 600-pa ... Full text Link to item Cite

An Updated Review of Iclaprim: A Potent and Rapidly Bactericidal Antibiotic for the Treatment of Skin and Skin Structure Infections and Nosocomial Pneumonia Caused by Gram-Positive Including Multidrug-Resistant Bacteria.

Journal article Open Forum Infect Dis · February 2018 New antibiotics are needed because of the increased morbidity and mortality associated with multidrug-resistant bacteria. Iclaprim, a bacterial dihydrofolate reductase inhibitor, not currently approved, is being studied for the treatment of skin infections ... Full text Link to item Cite

Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial.

Journal article Clin Infect Dis · January 6, 2018 BACKGROUND: Studies indicate that the prevalence of multidrug-resistant infections, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these ... Full text Link to item Cite

Digital ischaemia after intra-arterial drug injection.

Journal article BMJ Case Rep · September 25, 2017 Full text Link to item Cite

Suboptimal HIV Testing Among Patients Admitted With Pneumonia: A Missed Opportunity.

Journal article AIDS Educ Prev · August 2017 Patients admitted with pneumonia are at higher risk for HIV and should be routinely screened. We examined a retrospective cohort of patients admitted to Duke University Health System with a primary diagnosis of pneumonia. During the study period, 6,951 per ... Full text Link to item Cite

Gram-Positive Bacterial Infections: Research Priorities, Accomplishments, and Future Directions of the Antibacterial Resistance Leadership Group.

Journal article Clin Infect Dis · March 15, 2017 Antimicrobial resistance in gram-positive bacteria remains a challenge in infectious diseases. The mission of the Gram-Positive Committee of the Antibacterial Resistance Leadership Group (ARLG) is to advance knowledge in the prevention, management, and tre ... Full text Link to item Cite

Bacteremia, Sepsis, and Infective Endocarditis Associated with Staphylococcus aureus.

Journal article Curr Top Microbiol Immunol · 2017 Bacteremia and infective endocarditis (IE) are important causes of morbidity and mortality associated with Staphylococcus aureus infections. Increasing exposure to healthcare, invasive procedures, and prosthetic implants has been associated with a rising i ... Full text Link to item Cite

Contribution of urinary tract infection to the burden of febrile illnesses in young children in rural Kenya.

Journal article PLoS One · 2017 INTRODUCTION: The clinical features of UTI in young children may not localize to the urinary tract and closely resemble other febrile illnesses. In malaria endemic areas, a child presenting with fever is often treated presumptively for malaria without inve ... Full text Open Access Link to item Cite

Global initiative for meticillin-resistant Staphylococcus aureus pneumonia (GLIMP): an international, observational cohort study.

Journal article Lancet Infect Dis · December 2016 BACKGROUND: Antibiotic resistance is a major global health problem and pathogens such as meticillin-resistant Staphylococcus aureus (MRSA) have become of particular concern in the management of lower respiratory tract infections. However, few data are avai ... Full text Open Access Link to item Cite

Clinical and geographic patterns of rheumatic heart disease in outpatients attending cardiology clinic in western Kenya.

Journal article Int J Cardiol · November 15, 2016 INTRODUCTION: Rheumatic heart disease (RHD) remains a leading cause of cardiovascular mortality in sub-Saharan Africa. Identifying high risk populations and geographic patterns of disease is crucial to developing RHD prevention and screening strategies in ... Full text Link to item Cite

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis.

Journal article BMJ Open · November 10, 2016 OBJECTIVES: To explore patient, caregiver and physician perceptions and attitudes regarding the balance of benefit and risk in using antibacterial drugs developed through streamlined development processes. DESIGN: Semistructured focus groups and in-depth i ... Full text Link to item Cite

Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting.

Journal article Infect Dis Ther · September 2016 INTRODUCTION: Introduction of new antibiotics enabling single-dose administration, such as oritavancin may significantly impact site of care decisions for patients with acute bacterial skin and skin structure infections (ABSSSI). This analysis compared the ... Full text Link to item Cite

Infective endocarditis.

Journal article Nat Rev Dis Primers · September 1, 2016 Infective endocarditis (IE) is a rare, life-threatening disease that has long-lasting effects even among patients who survive and are cured. IE disproportionately affects those with underlying structural heart disease and is increasingly associated with he ... Full text Link to item Cite

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

Journal article Clin Infect Dis · August 15, 2016 BACKGROUND: The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial dr ... Full text Link to item Cite

Q Fever, Scrub Typhus, and Rickettsial Diseases in Children, Kenya, 2011-2012.

Journal article Emerg Infect Dis · May 2016 To increase knowledge of undifferentiated fevers in Kenya, we tested paired serum samples from febrile children in western Kenya for antibodies against pathogens increasingly recognized to cause febrile illness in Africa. Of patients assessed, 8.9%, 22.4%, ... Full text Open Access Link to item Cite

Identification of Patient Characteristics Influencing Setting of Care Decisions for Patients With Acute Bacterial Skin and Skin Structure Infections: Results of a Discrete Choice Experiment.

Journal article Clin Ther · March 2016 PURPOSE: Rates of acute bacterial skin and skin structure infections (ABSSSI) have sharply increased since 2000. Treatment may be administered in the inpatient or outpatient setting; clinical decision-making regarding hospitalization is inconsistent, often ... Full text Link to item Cite

Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management.

Journal article Clin Microbiol Rev · July 2015 Staphylococcus aureus is a major human pathogen that causes a wide range of clinical infections. It is a leading cause of bacteremia and infective endocarditis as well as osteoarticular, skin and soft tissue, pleuropulmonary, and device-related infections. ... Full text Link to item Cite

Bacteremia Caused by Kerstersia gyiorum.

Journal article J Clin Microbiol · June 2015 Kerstersia spp. are an unusual cause of human infections. We report the first known case of bacteremia and sepsis due to Kerstersia gyiorum, in a patient with chronic lower-extremity ulcers, and we review the literature on this uncommon pathogen. ... Full text Link to item Cite

Etiology of pediatric fever in western Kenya: a case-control study of falciparum malaria, respiratory viruses, and streptococcal pharyngitis.

Journal article Am J Trop Med Hyg · May 2015 In Kenya, more than 10 million episodes of acute febrile illness are treated annually among children under 5 years. Most are clinically managed as malaria without parasitological confirmation. There is an unmet need to describe pathogen-specific etiologies ... Full text Link to item Cite

Candida infective endocarditis: an observational cohort study with a focus on therapy.

Journal article Antimicrob Agents Chemother · April 2015 Candida infective endocarditis is a rare disease with a high mortality rate. Our understanding of this infection is derived from case series, case reports, and small prospective cohorts. The purpose of this study was to evaluate the clinical features and u ... Full text Link to item Cite

Impact of early valve surgery on outcome of Staphylococcus aureus prosthetic valve infective endocarditis: analysis in the International Collaboration of Endocarditis-Prospective Cohort Study.

Journal article Clin Infect Dis · March 1, 2015 BACKGROUND: The impact of early valve surgery (EVS) on the outcome of Staphylococcus aureus (SA) prosthetic valve infective endocarditis (PVIE) is unresolved. The objective of this study was to evaluate the association between EVS, performed within the fir ... Full text Link to item Cite

One-year outcome following biological or mechanical valve replacement for infective endocarditis.

Journal article Int J Cardiol · January 15, 2015 BACKGROUND: Nearly half of patients require cardiac surgery during the acute phase of infective endocarditis (IE). We describe the characteristics of patients according to the type of valve replacement (mechanical or biological), and examine whether the ty ... Full text Link to item Cite

Association between surgical indications, operative risk, and clinical outcome in infective endocarditis: a prospective study from the International Collaboration on Endocarditis.

Journal article Circulation · January 13, 2015 BACKGROUND: Use of surgery for the treatment of infective endocarditis (IE) as related to surgical indications and operative risk for mortality has not been well defined. METHODS AND RESULTS: The International Collaboration on Endocarditis-PLUS (ICE-PLUS) ... Full text Link to item Cite

Invasive gram-positive bacterial infection in cancer patients.

Journal article Clin Infect Dis · November 15, 2014 Systematic studies have shown that gram-positive organisms are the leading cause of invasive bacterial disease in patients with cancer. A broad range of gram-positive bacteria cause serious infections in the cancer patient with the greatest burden of disea ... Full text Link to item Cite

Clinical management of Staphylococcus aureus bacteremia: a review.

Journal article JAMA · October 1, 2014 IMPORTANCE: Several management strategies may improve outcomes in patients with Staphylococcus aureus bacteremia. OBJECTIVES: To review evidence of management strategies for S. aureus bacteremia to determine whether transesophageal echocardiography is nece ... Full text Link to item Cite

Blood pressure level impacts risk of death among HIV seropositive adults in Kenya: a retrospective analysis of electronic health records.

Journal article BMC Infect Dis · May 22, 2014 BACKGROUND: Mortality among people with human immunodeficiency virus (HIV) infection is increasingly due to non-communicable causes. This has been observed mostly in developed countries and the routine care of HIV infected individuals has now expanded to i ... Full text Open Access Link to item Cite

Blood pressure level impacts risk of death among HIV seropositive adults in Kenya: A retrospective analysis of electronic health records

Journal article BMC Infectious Diseases · 2014 Background: Mortality among people with human immunodeficiency virus (HIV) infection is increasingly due to non-communicable causes. This has been observed mostly in developed countries and the routine care of HIV infected individuals has now expanded to i ... Full text Cite

High-dose daptomycin therapy for left-sided infective endocarditis: a prospective study from the international collaboration on endocarditis.

Journal article Antimicrob Agents Chemother · December 2013 The use of daptomycin in Gram-positive left-sided infective endocarditis (IE) has significantly increased. The purpose of this study was to assess the influence of high-dose daptomycin on the outcome of left-sided IE due to Gram-positive pathogens. This wa ... Full text Open Access Link to item Cite

Influence of the timing of cardiac surgery on the outcome of patients with infective endocarditis and stroke.

Journal article Clin Infect Dis · January 2013 BACKGROUND: The timing of cardiac surgery after stroke in infective endocarditis (IE) remains controversial. We examined the relationship between the timing of surgery after stroke and the incidence of in-hospital and 1-year mortalities. METHODS: Data were ... Full text Link to item Cite

HACEK infective endocarditis: characteristics and outcomes from a large, multi-national cohort.

Journal article PLoS One · 2013 The HACEK organisms (Haemophilus species, Aggregatibacter species, Cardiobacterium hominis, Eikenella corrodens, and Kingella species) are rare causes of infective endocarditis (IE). The objective of this study is to describe the clinical characteristics a ... Full text Link to item Cite

Reply to gould

Journal article Journal of Infectious Diseases · March 1, 2012 Full text Cite

Antibacterial susceptibility testing in the clinical laboratory.

Journal article Infect Dis Clin North Am · December 2009 This article familiarizes the clinician with the principles of bacterial susceptibility testing and reporting to facilitate communication with the clinical microbiology laboratory. As resistance continues to emerge among a wide range of clinically relevant ... Full text Link to item Cite