Efficacy and safety of cefepime in pediatric patients: a systematic review and meta-analysis.
OBJECTIVE
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.


METHODS
We searched the Cochrane Central Registry of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and other published and unpublished sources.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
Sixteen 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.
Adderson
Elisabeth E
EE
Department of Infectious Diseases, St. Jude Children's Research Hospital, Department of Pediatrics, The University of Tennessee Health Sciences Center, Memphis TN 38105, USA. elisabeth.adderson@stjude.org
Flynn
Patricia M
PM
Hoffman
James M
JM
D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D000077723:Cefepime; D002511:Cephalosporins / Q000009:adverse effects*; D002648:Child; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000077723:Cefepime