Cefepime Monotherapy is as Effective as Ceftriaxone Plus Amikacin in Pediatric Patients with Cancer and High-Risk Febrile Neutropenia: A Randomized Comparison

The empirical use of antibiotic therapies is widely accepted in patients with fever and neutropenia during cancer chemotherapy. The use of intravenous monotherapy with broad- spectrum antibiotics in patients with high- risk of complications is an appropriate alternative. However, few data are available in pediatric patients. We conducted a prospective, randomized, open study in patients with lymphoma or leukemia who had fever and neutropenia during chemotherapy. Patients were randomized to receive cefepime (CFP) or ceftriaxone plus amikacin (CFT+ AK). A total of 57 patients with 125 episodes of fever and neutropenia were evaluated (CFP, 62 and CFT + AK, 63 episodes). The mean neutrophil count at admission was 118.6 cells mm(-3) (CFP) and 107 cells mm(-3) (CFT+ AK). The mean duration of neutropenia was 9.0 days (CFP) and 8.0 days (CFT+ AK). Analyzing only the first episodes of each patient, CFP treatment was successful in 65.5% of the episodes and CFT+ AK were successful in 64.3%. Overall rates of success with modification were 90% (CFP) and 89% (CFT+ AK). No major treatment- emergent toxicity was reported. Monotherapy with CFP seems to be as effective and safe as the combination of CFT+ AK for initial empirical therapy in children and adolescents with NF.