Abstract

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. 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). 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. 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.

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