Efficacy and Safety of Cefepime in Pediatric Patients: A Systematic Review and Meta-Analysis

Objectives We systematically reviewed clinical trials on the safety and efficacy of cefepime in pediatric patients in view of recent reports, which suggested that cefepime is associated with increased 30-day all-cause mortality rates. Study design We searched the Cochrane Central Registry of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and other published and unpublished sources. Randomized clinical trials of cefepime in patients < 19 years of age were selected. Results Sixteeen clinical trials were included. All-cause mortality rates did not differ between cefepime and comparator groups (risk difference, 0.00; 95% CI, -0.01-0.02). The risks of overall clinical failure (relative risk, 0.93; 95% CI, 0.82-1.04; P > .05) and failure in microbiologically confirmed infections (relative risk, 0.91; 95% CI, 0.68-1.22; P > .05) were not greater in subjects treated with cefepime. Rates of adverse events were similar in each group in all trials except 1. All studies had significant methodological flaws. Conclusions Comparisons of the safety and efficacy of cefepime relative with other antimicrobial agents in pediatric patients are limited by small numbers of trials and enrolled subjects and poor study methodology. This review, however, suggests that cefepime therapy in pediatric patients is not associated with an increased risk of adverse outcomes. (J Pediatr 2010; 157: 490-5).