Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections.

ABSTRACT:

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 infan

SUBMITTER: Commander SJ 

PROVIDER: S-EPMC10060863 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature