CEFEPIME VS. CEFTAZIDIME TREATMENT OF PYELONEPHRITIS - A EUROPEAN, RANDOMIZED CONTROLLED-STUDY OF 300 PEDIATRIC CASES

Background. Cefepime has been used in clinical therapeutic trials for meningitis, serious infection and febrile neutropenia, comprising more than 800 pediatric patients, This agent has also been used in patient s 12 years of age and older with uncomplicated and complicated urinary tract infections including pyelonephritis, but not in younger patient s. In this study the safety and efficacy of cefepime were compared wit h those of ceftazidime for treatment of pyelonephritis in pediatric pa tients younger than 12 years of age. Methods, Two hundred ninety-nine pediatric patients (ages 1 month to 12 years) with pyelonephritis (300 episodes) were enrolled in a randomized, open label, multicenter tria l. Individual results were evaluated by a blinded committee of experts . Cefepime was compared with ceftazidime, both administered parenteral ly at 50 mg/kg every 8 h, Patients were to receive the assigned study drug until at least 48 h after becoming afebrile, The iv treatment was then to be continued or replaced by oral trimethoprim-sulfamethoxazol e for a maximum of 12 to 14 days. Results. The predominant causative p athogens were Escherichia coli, 88%; Proteus spp,, 6%; Pseudomonas aer uginosa, 2%; and Klebsiella spp,, 2%, Bacteriologic eradication was ac hieved in 96 and 94% of cefepime and ceftazidime patients, respectivel y, at the end of iv study drug treatment and was maintained in 94 and 91%, respectively at the end of total study therapy. After study thera py bacteriologic eradication was maintained after 4 to 6 weeks in 86% of cefepime cases and in 83% of ceftazidime cases. A satisfactory clin ical response occurred in 98 and 96% of cefepime and ceftazidime patie nts, respectively, at the end of iv treatment and in 93% at the end of total study therapy in both treatment arms. Drug-related clinical adv erse events occurred in 14 cefepime patients (9%) and in 10 ceftazidim e patients (7%), Conclusions. Cefepime and ceftazidime are equally saf e and efficacious treatment for pyelonephritis in pediatric patients.