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Cefepine vs. ceftazidime treatment of pyelonephritis: a European, randomized, controlled study of 300 pediatric
U B Schaad1, J Eskola, D Kafetzis
1Department of Pediatrics, University Children's Hospital, Basel, Switzerland. schaad@ubaclu.unibas.ch
Insights
Cefepime and ceftazidime demonstrate equal safety and efficacy in treating pediatric pyelonephritis. This study confirms both antibiotics are effective for kidney infections in children under 12.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology and Therapeutics
- Nephrology
Background:
- Cefepime, a broad-spectrum cephalosporin, has established efficacy in various pediatric infections.
- Previous studies utilized cefepime in pediatric patients for meningitis, serious infections, and febrile neutropenia.
- Cefepime's use was previously restricted to patients 12 years and older for urinary tract infections.
Purpose of the Study:
- To compare the safety and efficacy of cefepime versus ceftazidime for treating pyelonephritis in pediatric patients younger than 12 years.
- To evaluate bacteriologic eradication and clinical response rates in pediatric patients receiving cefepime or ceftazidime.
- To assess drug-related adverse events associated with cefepime and ceftazidime treatment in children.
Main Methods:
- A randomized, open-label, multicenter trial involving 299 pediatric patients (1 month to 12 years) with 300 episodes of pyelonephritis.
- Patients received either cefepime or ceftazidime parenterally at 50 mg/kg every 8 hours.
- Treatment continued until afebrile for 48 hours, followed by oral trimethoprim-sulfamethoxazole for up to 14 days.
Main Results:
- Predominant pathogens included Escherichia coli (88%), Proteus spp. (6%), Pseudomonas aeruginosa (2%), and Klebsiella spp. (2%).
- Bacteriologic eradication rates were high and comparable: 96% for cefepime and 94% for ceftazidime post-IV therapy, maintained at 94% and 91% respectively post-total therapy.
- Satisfactory clinical response rates were also similar: 98% for cefepime and 96% for ceftazidime post-IV therapy, and 93% in both arms post-total therapy. Drug-related adverse events were infrequent.
Conclusions:
- Cefepime and ceftazidime are equally safe and effective treatments for pyelonephritis in pediatric patients.
- Both antibiotics achieve high rates of bacteriologic eradication and clinical success in children with pyelonephritis.
- The study supports the use of cefepime in younger pediatric patients for the treatment of pyelonephritis.
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 patients 12 years of age and older with uncomplicated and complicated urinary tract infections including pyelonephritis, but not in younger patients. In this study the safety and efficacy of cefepime were compared with those of ceftazidime for treatment of pyelonephritis in pediatric patients 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 trial. Individual results were evaluated by a blinded committee of experts. Cefepime was compared with ceftazidime, both administered parenterally at 50 mg/kg every 8 h. Patients were to receive the assigned study drug until at least 48 h after becoming afebrile. The i.v. treatment was then to be continued or replaced by oral trimethoprimsulfamethoxazole for a maximum of 12 to 14 days.
Results:
The predominant causative pathogens were Escherichia coli, 88%; Proteus spp., 6%; Pseudomonas aeruginosa, 2%; and Klebsiella spp., 2%. Bacteriologic eradication was achieved in 96 and 94% of cefepime and ceftazidime patients, respectively, at the end of i.v. study drug treatment and was maintained in 94 and 91%, respectively, at the end of total study therapy. After study therapy bacteriologic eradication was maintained after 4 to 6 weeks in 86% of cefepime cases and in 83% of ceftazidime cases. A satisfactory clinical response occurred in 98 and 96% of cefepime and ceftazidime patients, respectively, at the end of i.v. treatment and in 93% at the end of total study therapy in both treatment arms. Drug-related clinical adverse events occurred in 14 cefepime patients (91%) and in 10 ceftazidime patients (7%).
Conclusions:
Cefepime and ceftazidime are equally safe and efficacious treatment for pyelonephritis in pediatric patients.