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

Publication ,  Journal Article
Smith, MJ; Boutzoukas, A; Autmizguine, J; Hudak, ML; Zinkhan, E; Bloom, BT; Heresi, G; Lavery, AP; Courtney, SE; Sokol, GM; Cotten, CM; Gao, J ...
Published in: 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 this population. METHODS: Infants ≤33 weeks gestational age and <121 days postnatal age with cIAI were randomized to ≤10 days of ampicillin, gentamicin, and metronidazole (group 1); ampicillin, gentamicin, and clindamycin (group 2); or piperacillin-tazobactam and gentamicin (group 3) at doses stratified by postmenstrual age. Due to slow enrollment, a protocol amendment allowed eligible infants already receiving study regimens to enroll without randomization. The primary outcome was mortality within 30 days of study drug completion. Secondary outcomes included adverse events, outcomes of special interest, and therapeutic success (absence of death, negative cultures, and clinical cure score >4) 30 days after study drug completion. RESULTS: One hundred eighty infants [128 randomized (R), 52 nonrandomized (NR)] were enrolled: 63 in group 1 (45 R, 18 NR), 47 in group 2 (41 R, 6 NR), and 70 in group 3 (42 R, 28 NR). Thirty-day mortality was 8%, 7%, and 9% in groups 1, 2, and 3, respectively. There were no differences in safety outcomes between antibiotic regimens. After adjusting for treatment group and gestational age, mortality rates through end of follow-up were 4.22 [95% confidence interval (CI): 1.39-12.13], 4.53 (95% CI: 1.21-15.50), and 4.07 (95% CI: 1.22-12.70) for groups 1, 2, and 3, respectively. CONCLUSIONS: Each of the antibiotic regimens are safe in premature infants with cIAI. CLINICAL TRIAL REGISTRATION: NCT0199499.

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Published In

Pediatr Infect Dis J

DOI

EISSN

1532-0987

Publication Date

June 1, 2021

Volume

40

Issue

6

Start / End Page

550 / 555

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Pediatrics
  • Intraabdominal Infections
  • Infant, Premature
  • Infant, Newborn
  • Infant
  • Humans
  • Anti-Bacterial Agents
  • 3213 Paediatrics
 

Citation

APA
Chicago
ICMJE
MLA
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Smith, M. J., Boutzoukas, A., Autmizguine, J., Hudak, M. L., Zinkhan, E., Bloom, B. T., … Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee, . (2021). Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J, 40(6), 550–555. https://doi.org/10.1097/INF.0000000000003034
Smith, Michael J., Angelique Boutzoukas, Julie Autmizguine, Mark L. Hudak, Erin Zinkhan, Barry T. Bloom, Gloria Heresi, et al. “Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.Pediatr Infect Dis J 40, no. 6 (June 1, 2021): 550–55. https://doi.org/10.1097/INF.0000000000003034.
Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, et al. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550–5.
Smith, Michael J., et al. “Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.Pediatr Infect Dis J, vol. 40, no. 6, June 2021, pp. 550–55. Pubmed, doi:10.1097/INF.0000000000003034.
Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp J-H, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK, Hornik CP, Smith PB, Cohen-Wolkowiez M, Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550–555.

Published In

Pediatr Infect Dis J

DOI

EISSN

1532-0987

Publication Date

June 1, 2021

Volume

40

Issue

6

Start / End Page

550 / 555

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Pediatrics
  • Intraabdominal Infections
  • Infant, Premature
  • Infant, Newborn
  • Infant
  • Humans
  • Anti-Bacterial Agents
  • 3213 Paediatrics