Validation study of new febrile neutropenia guideline-Comparative study between oral levofloxacin and parenteral cefepime in low-risk patients with febrile neutropenia

UMIN ID: C000000396

Registered date:04/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Febrile neutropenia
• Date of first enrollment: 2005/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

CFPM 4g,1h-div, q12
LVFX 200mg, tid

Outcome(s)

• Primary Outcome: Treatment efficacy at 7 days after antimicrobiral therapy
• Secondary Outcome: Adverse events, treatment results in 3-5 days after the start of therapy, succes rate as an outpatient, survival, antibacterial effect

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Poor-risk acute leukemia patients Isolation of microorganism resistant to the study drugs Past history of allergy to beta-lactum or study drugs Pregnant or lactating woman Age of 15 years or younger Antimicrobial treatment within 3 months prior to the study entry Allegenic hematopoietic stem cell transplantation

Related Information

• Primary Sponsor: Japan Febrile Neutropenia Study Group
• Source(s) of Monetary Support: Japan Febrile Neutropenia Study Group