Background: Ciprofloxacin (CPFX) is a potential alternative in patients with febrile neutropenia (FN) because of its activity against Gram-negative organisms. We conducted a non-inferiority, open-label, randomized controlled trial comparing intravenous CPFX and cefepime (CFPM) for FN patients with hematological malignancies.
Methods: Patients aged from 15 to 79 years with an absolute neutrophil count of <0.500 x 10(9)/l were eligible, and were randomized to receive 300 mg of CPFX or 2 g of CFPM every 12 h. Initial treatment efficacy, overall response, and early toxicity were evaluated.
Results: Fifty-one episodes were included in this trial, and 49 episodes (CPFX vs. CFPM: 24 vs. 25) were evaluated. Treatment efficacy at day 7 was significantly higher in the CFPM group (successful clinical response: nine with CPFX and 19 with CFPM; p = 0.007). The response was better in high-risk patients with neutrophil counts of <= 0.100 x 10(9)/l (p = 0.003). The overall response during the study period was similar between the CPFX and CFPM groups (p = 0.64). Adverse events were minimal, and all patients could continue the treatment.
Conclusions: We could not prove the non-inferiority of CPFX in comparison with CFPM for the initial treatment of FN. CFPM remains the standard treatment of choice for FN. (C) 2013 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.