A randomized trial of cefozopran versus cefepime as empirical antibiotic treatment of febrile neutropenia in pediatric cancer patients.

BACKGROUND: Febrile neutropenia (FN) is a common and serious complication of cancer chemotherapy associated with significant morbidity and mortality. Cefozopran (CZOP) is a potential candidate for empirical monotherapy in FN. However, studies on the use of CZOP as empirical treatment for pediatric patients with FN are quite limited. The purpose of this study was to compare the efficacy and safety of CZOP with cefepime (CFPM) empirical monotherapy in pediatric cancer patients with FN.

PROCEDURES: A total of 64 patients with 224 episodes of FN were randomly assigned to receive antibiotic therapy with either CZOP (100 mg/kg/day) or CFPM (100 mg/kg/day). Of these episodes, 223 were considered eligible for the study. Success was defined as resolution of febrile episodes and clinical signs of infection within 120 hr following the start of antibiotic therapy.

RESULTS: The success rate was not significantly different between the CZOP (64.0%) and CFPM (56.3%) groups (P = 0.275). Duration of fever, duration of antibiotic therapy, and the success rate in patients with blood stream infection did not differ between the two groups. There was no infection-related mortality in the study period.

CONCLUSION: Both CZOP and CFPM as monotherapy appear to be effective and safe in pediatric patients. This study suggests that CZOP has satisfactory efficacy and is well tolerated as initial empirical therapy for pediatric cancer patients with FN.