Safety of Metronidazole in Late Preterm and Term Infants with Complicated Intraabdominal Infections
| Autor: | Julie Debski, Erin K Zinkhan, Fernando Moya, Sarah Jane Commander, Paula Delmore, Gaurav Sharma, Gloria Heresi, Christoph P. Hornik, Jinson Erinjeri, Tedryl G Bumpass, Gregory M Sokol, P. Brian Smith, Adrian Lavery, Sherry E. Courtney, Jamie Gao, Michael Cohen-Wolkowiez, Elisabeth T. Tracy, Daniel K. Benjamin |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Microbiology (medical)
Male Pediatrics medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Exploratory laparotomy medicine.drug_class medicine.medical_treatment Antibiotics Gestational Age Article Cohort Studies 03 medical and health sciences 0302 clinical medicine 030225 pediatrics Multicenter trial Ampicillin Metronidazole medicine Humans 030212 general & internal medicine business.industry Infant Newborn Gestational age Infant Rash United States Anti-Bacterial Agents Infectious Diseases Pediatrics Perinatology and Child Health Vancomycin Intraabdominal Infections Drug Therapy Combination Female medicine.symptom business medicine.drug |
| Zdroj: | Pediatr Infect Dis J |
| Popis: | 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 (SCAMP) open-label multicenter trial infants ≥34 weeks gestation at birth and 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 adverse event, 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 one (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. |
| Databáze: | OpenAIRE |
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