title: Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies.
abstract: 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.
authors: Department of Hematology and Oncology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
authors: Takahiko
authors: T
authors: Yasuda
authors: Ritsuro
authors: R
authors: Suzuki
authors: Yuichi
authors: Y
authors: Ishikawa
authors: Seitaro
authors: S
authors: Terakura
authors: Yoshihiro
authors: Y
authors: Inamoto
authors: Masamitsu
authors: M
authors: Yanada
authors: Hirokazu
authors: H
authors: Nagai
authors: Yukiyasu
authors: Y
authors: Ozawa
authors: Kazutaka
authors: K
authors: Ozeki
authors: Yoshiko
authors: Y
authors: Atsuta
authors: Nobuhiko
authors: N
authors: Emi
authors: Tomoki
authors: T
authors: Naoe
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077723:Cefepime; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology*; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D002939:Ciprofloxacin; D000077723:Cefepime