UMIN ID: UMIN000000462
Registered date:04/08/2006
Validation study VI of febrile neutropenia guideline 2004
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 | 400 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | CFPM 2g, 3h-div, q12h MEPM 1g, 3h-div, q12h IPM/CS 1g, 3h-div, q12h CZOP 2g, 3h-div, q12h |
Outcome(s)
| Primary Outcome | Treatment efficacy for 7-day period after antimicrobiral therapy |
|---|---|
| Secondary Outcome | Efficacy at day 3-5, 14, 30 Safety |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Japan Febrile Neutropenia Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Febrile Neutropenia Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuo Tamura |
| Address | 7-45-1, Nanakuma, Jonan-ku, Fukuoka Japan |
| Telephone | 092-801-1011 |
| Affiliation | Fukuoka University Depatment of Internal Medicine |
| scientific contact | |
| Name | Akihisa Kanamaru |
| Address | 377-2 Ohno-Higashi, Osaka-Sayama, Osaka Japan |
| Telephone | |
| Affiliation | Kinki University Department of Hematology |