PMID- 32453198 OWN - NLM STAT- MEDLINE DCOM- 20210715 LR - 20240407 IS - 1532-0987 (Electronic) IS - 0891-3668 (Print) IS - 0891-3668 (Linking) VI - 39 IP - 9 DP - 2020 Sep TI - Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections. PG - e245-e248 LID - 10.1097/INF.0000000000002698 [doi] AB - 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 Safety in Infants with Complicated Intra-Abdominal Infections open-label multicenter trial infants >/=34 weeks gestation at birth and <121 days postnatal age with cIAIs were administered metronidazole as part of multimodal therapy. Metronidazole safety was evaluated by reporting of adverse events (AEs) and safety events of special interest. Cure from disease was determined by blood cultures and a clinical cure score >4. A blinded adjudication committee reviewed all safety events of special interest. RESULTS: Fifty-five infants were included, median gestational age was 36 weeks (range: 34-41) and postnatal age was 7 days (0-63). The most common additional antibiotics received included gentamicin, piperacillin-tazobactam, ampicillin and vancomycin. Only one AE, a candidal rash, was identified to be potentially caused by metronidazole administration. One infant died of cardiopulmonary failure, which was deemed unrelated to metronidazole. The most common events of special interest included feeding intolerance in 18 (33%) infants, and exploratory laparotomy in 10 (18%) requiring intestinal anastomosis in 7 (13%) infants. There was 1 (2%) intestinal stricture. Fifty-three infants (96%) achieved overall therapeutic success, 54 (98%) were alive through 30 days post-study therapy, and 54 (98%) had 30-day clinical cure score >4. CONCLUSIONS: In a cohort of late pre-term and term infants with cIAIs, combination antibiotic therapy that included metronidazole was safe, and therapeutic success was high. FAU - Commander, Sarah Jane AU - Commander SJ AD - Department of Surgery, Duke University Medical Center, Durham, North Carolina. AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Gao, Jamie AU - Gao J AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Zinkhan, Erin K AU - Zinkhan EK AD - Department of Pediatrics, Division of Neonatology, Intermountain Medical Center, University of Utah, Salt Lake City, Utah. FAU - Heresi, Gloria AU - Heresi G AD - Department of Pediatrics, Division of Pediatric Infectious Diseases, University of Texas, Houston, Texas. FAU - Courtney, Sherry E AU - Courtney SE AD - Department of Pediatrics, Division of Neonatology, University of Arkansas for Medical Sciences, Little Rock, Arkansas. FAU - Lavery, Adrian P AU - Lavery AP AD - Department of Pediatrics, Division of Neonatology, Loma Linda University, Loma Linda, California. FAU - Delmore, Paula AU - Delmore P AD - Department of Pediatrics, Wichita Medical Research and Education Foundation, Wichita, Kansas. FAU - Sokol, Gregory M AU - Sokol GM AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Moya, Fernando AU - Moya F AD - Department of Pediatrics, Coastal Carolina Neonatology, Wilmington, North Carolina. FAU - Benjamin, Danny AU - Benjamin D AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Bumpass, Tedryl G AU - Bumpass TG AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Debski, Julie AU - Debski J AD - The Emmes Company LLC, Rockville, Maryland. FAU - Erinjeri, Jinson AU - Erinjeri J AD - The Emmes Company LLC, Rockville, Maryland. FAU - Sharma, Gaurav AU - Sharma G AD - The Emmes Company LLC, Rockville, Maryland. FAU - Tracy, Elisabeth T AU - Tracy ET AD - Department of Surgery, Duke University Medical Center, Durham, North Carolina. FAU - Smith, P Brian AU - Smith PB AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Cohen-Wolkowiez, Michael AU - Cohen-Wolkowiez M AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. FAU - Hornik, Christoph P AU - Hornik CP AD - Department of Pediatrics, Division of Pediatric Research, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. CN - Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee LA - eng GR - HHSN275201000003C/AA/NIAAA NIH HHS/United States GR - HHSN275201000003I/HD/NICHD NIH HHS/United States GR - T32 GM086330/GM/NIGMS NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PL - United States TA - Pediatr Infect Dis J JT - The Pediatric infectious disease journal JID - 8701858 RN - 0 (Anti-Bacterial Agents) RN - 140QMO216E (Metronidazole) SB - IM MH - Anti-Bacterial Agents/standards/*therapeutic use MH - Cohort Studies MH - Drug Therapy, Combination MH - Drug-Related Side Effects and Adverse Reactions MH - Female MH - Gestational Age MH - Humans MH - Infant MH - Infant, Newborn MH - Intraabdominal Infections/*drug therapy/*microbiology MH - Male MH - Metronidazole/standards/*therapeutic use MH - United States PMC - PMC10060863 MID - NIHMS1814176 COIS- Conflict of Interest: The authors have no conflict of interests to disclose EDAT- 2020/05/27 06:00 MHDA- 2021/07/16 06:00 PMCR- 2023/03/30 CRDT- 2020/05/27 06:00 PHST- 2020/05/27 06:00 [pubmed] PHST- 2021/07/16 06:00 [medline] PHST- 2020/05/27 06:00 [entrez] PHST- 2023/03/30 00:00 [pmc-release] AID - 00006454-202009000-00023 [pii] AID - 10.1097/INF.0000000000002698 [doi] PST - ppublish SO - Pediatr Infect Dis J. 2020 Sep;39(9):e245-e248. doi: 10.1097/INF.0000000000002698.