Cefepime monotherapy is as effective as ceftriaxone plus amikacin in pediatric patients with cancer and high-risk febrile neutropenia in a randomized comparison.

BACKGROUND AND PURPOSE The empirical use of antibiotic therapy is widely accepted for patients with fever and neutropenia during cancer chemotherapy. The use of intravenous monotherapy with broad-spectrum antibiotics in patients at high risk for complications is an appropriate alternative. However, few data are available for pediatric patients. The aim of this study was to compare the efficacy and safety of cefepime (CFP) monotherapy with ceftriaxone plus amikacin (CFT+AK) in children and adolescents with febrile neutropenia (FN). METHODS A prospective randomized open study of patients with lymphoma or leukemia who had fever and neutropenia during chemotherapy was conducted. Patients were randomized to receive CFP or CFT+AK. The randomization was based on number lists. RESULTS Fifty seven patients with 125 episodes of fever and neutropenia were evaluated (CFP, 62 episodes; CFT+AK, 63 episodes). The mean neutrophil count at admission to hospital was 118.6 cells/mm(3) for patients in the CFP group and 107 cells/mm(3) for patients in the CFT+AK group. The mean duration of neutropenia was 9 days for the CFP group and 8 days for the CFT+AK group. Analysis of only the first episodes for each patient showed that CFP treatment was successful for 65.5% of episodes and CFT+AK was successful for 64.3% of episodes. The overall rates of success with modification were 90% for the CFP group and 89% for the CFT+AK group. No major treatment-emergent toxicity was reported. CONCLUSION Monotherapy with CFP seems to be as effective and safe as CFT+AK for initial empirical therapy in children and adolescents with FN.