Background: These studies were designed to assess the efficacy and safety of cefepime, a fourth generation cephalosporin, for the treatment of serious infections, including lower respiratory tract infections (LRTI) in children.
Methods: Four clinical trials of cefepime for the treatment of serious bacterial infections enrolled 259 children with LRTI. In 3 trials cefepime was compared with ceftazidime (n = 166), cefotaxime (n = 16) or cefuroxime (n = 12). One trial was noncomparative (n = 65).
Results: Treatment with cefepime 50 mg/kg/ dose administered every 8 to 12 h produced a satisfactory clinical response (clinical signs of infection resolved or improved with no evidence of recurrent infection at posttreatment follow-up) in 88 to 100% of patients, comparable with comparator therapy. In children from whom a causative pathogen was identified, bacteriologic eradication was comparable between cefepime and comparator therapy. Cefepime was as safe and well-tolerated as comparator therapy. Few treatment-related clinical or laboratory adverse events were noted and were equivalent to comparator in all studies.
Conclusion: Cefepime is as effective, safe and well-tolerated for the empiric treatment of children with LRTI as comparator agents but offers the advantage of an enhanced spectrum of activity for Gram-positive and Gram-negative pathogens compared with second or third generation cephalosporins.