Validation study VI of febrile neutropenia guideline 2004
Phase 3
- Conditions
- Febrile Neutropenia
- Registration Number
- JPRN-UMIN000000462
- Lead Sponsor
- Japan Febrile Neutropenia Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1.Isolation of microorgaism resistant to the study drug 2.Serious cardiac, liver or renal dysfunction 3.Past history of allergy to beta-lactum 4.Allergic diathesis 5.Positive skin reaction to study drug if it has to be done by each institution's regulation 6.Elderly patients who can not be evaluated for efficacy 7.Pregnant or lactating woman 8.Age of 15 years or younger 9.Antimicrobial treatment within 3 months prior to the study entry 10.Allogenic hematopoietic stem cell transplantation and older person 11.Patients to exclude from the study by primary physician's decision
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment efficacy for 7-day period after antimicrobiral therapy
- Secondary Outcome Measures
Name Time Method Efficacy at day 3-5, 14, 30 Safety