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

Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.


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 300 mg 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Algorithms
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Cefepime
  • Cephalosporins / administration & dosage
  • Cephalosporins / adverse effects
  • Cephalosporins / therapeutic use*
  • Ciprofloxacin / administration & dosage
  • Ciprofloxacin / adverse effects
  • Ciprofloxacin / therapeutic use*
  • Female
  • Fever / drug therapy*
  • Fever / etiology*
  • Hematologic Neoplasms / complications*
  • Humans
  • Male
  • Middle Aged
  • Neutropenia / drug therapy*
  • Neutropenia / etiology*
  • Treatment Outcome
  • Young Adult


  • Anti-Bacterial Agents
  • Cephalosporins
  • Ciprofloxacin
  • Cefepime