Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)

UMIN ID: C000000083

Registered date:29/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Febrile neutropenia
• Date of first enrollment: 2005/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

CPFX 300mg, 1h-div, q12h.
CFPM 2g, 1h-div, q12h.

Outcome(s)

• Primary Outcome: Treatment efficacy at 7 days after initiating therapy
• Secondary Outcome: Time to achieve defervescence, treatment efficacy at 21 days, toxicity

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (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

Related Information

• Primary Sponsor: Center for Supporting Hematology-Oncology Trials (C-SHOT)
• Source(s) of Monetary Support: Bayer Pharmaceutics Corporation
• Secondary ID(s): NCT00137787