Antibiotic Safety and Effectiveness in Premature Infants with Complicated Intraabdominal Infections

Michael J. Smith, Angelique Boutzoukas, Julie Autmizguine, Mark L. Hudak, Erin Zinkhan, Barry T. Bloom, Gloria Heresi, Adrian P. Lavery, Sherry E. Courtney, Gregory M. Sokol, C. Michael Cotten, Joseph M. Bliss, Susan Mendley, Catherine Bendel, Christiane E.L. Dammann, Jörn Hendrik Weitkamp, Matthew A. Saxonhouse, Gratias T. Mundakel, Julie Debski, Gaurav SharmaJinson Erinjeri, Jamie Gao, Daniel K. Benjamin, Christoph P. Hornik, P. Brian Smith, Michael Cohen-Wolkowiez

Research output: Contribution to journalArticlepeer-review

10 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)550-555
Number of pages6
JournalPediatric Infectious Disease Journal
Issue number6
StatePublished - Jun 1 2021

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© 2021 Lippincott Williams and Wilkins. All rights reserved.


  • antibiotics
  • complicated intraabdominal infection
  • infants
  • safety


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