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Efficacy and safety of cefepime in pediatric patients: a systematic review and meta-analysis
Elisabeth E Adderson1, Patricia M Flynn, James M Hoffman
1Department 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
Insights
This systematic review found no increased risk of death or treatment failure in pediatric patients receiving cefepime compared to other antibiotics. While studies had flaws, cefepime appears safe for children.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- Recent reports raised concerns about cefepime's safety in pediatric patients, specifically regarding increased mortality.
- Cefepime is a broad-spectrum cephalosporin antibiotic used for various bacterial infections.
Purpose of the Study:
- To systematically review and synthesize evidence from clinical trials on the safety and efficacy of cefepime in pediatric populations.
- To address concerns about cefepime's association with increased all-cause mortality rates in children.
Main Methods:
- Systematic literature search of major databases (CENTRAL, MEDLINE, EMBASE) and other sources.
- Inclusion of randomized clinical trials involving cefepime in patients under 19 years of age.
- Meta-analysis of mortality, clinical failure, and adverse event rates.
Main Results:
- Sixteen trials were included; no significant difference in 30-day all-cause mortality between cefepime and comparator groups.
- Cefepime was not associated with increased risks of overall clinical failure or failure in microbiologically confirmed infections.
- Adverse event rates were similar across groups, with one exception; however, all studies exhibited methodological limitations.
Conclusions:
- Despite limitations in trial numbers and study quality, this review suggests cefepime therapy is not linked to higher adverse outcomes in pediatric patients.
- Further high-quality research is needed to definitively establish cefepime's safety and efficacy profile in children.
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:
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.
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