Cefepime (CEP) vs Ceftazidime (CAZ) in the treatment of pyelonephritis. A european study of 300 children

This open, comparative, centrally randomized study was conducted in 39 European ESPID centers in 1996, to compare CEP and CAZ, both 50 mg/kg q8h in the treatment of documented pyelonephritis in children. Oral continuation antibiotic therapy was allowed, as was long-term prophylaxis. Response to therapy was assessed at the end of IV therapy, end of IV+oral therapy and at early (Day+5/+9) and late (Week+4/+6) controls. Among the 300 patients included, 235 (78%) were evaluable for efficacy analysis, as assessed by the ESPID Scientific Committee blinded review. All patients characteristics were comparable between treatment groups, including age (52% aged < 2y) and presence of risk factors (46%), Total treatment duration was 14 (10-42) days. Predominant pathogens were E. coli (88%), Proteus sp (6%), P. aeruginosa (2%) and Klebsiella sp (2%). Initial eradication rates were comparable at end of IV therapy (99% vs 100%) as were maintained eradication at end of total therapy (100% vs 96%), early (95% vs 98%) and late (99% vs 92%) controls. Clinical response rates were similar (CEP: 98% at all controls, CAZ: 92% to 100%). Both treatments were well tolerated (91% without related events). Based on those results, cefepime is as safe and efficacious as ceftazidime for treatment of documented pyelonephritis in pediatric patients.