Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies

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 <0.500×10^9/l were eligible, and were randomized to receive 300mg of CPFX or 2g of CFPM every 12h. 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 ≤0.100×10^9/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.