Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)
- Conditions
- Febrile neutropenia
- Registration Number
- JPRN-C000000083
- Lead Sponsor
- Center for Supporting Hematology-Oncology Trials (C-SHOT)
- Brief Summary
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 less or equal to 100/microliter (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
(1) Past history of allergic reaction to the study drug (2) Positive for HIV antibody (3) Pregnant or lactating woman (4) Family history of auditory disturbance (5) Having received systemic antibacterial therapy within 14 days (6) Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation (7) No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode (8) On treatment with ketoprofen (9) On treatment with sodium valproate (10) Septic shock
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method