UMIN ID: UMIN000000630
Registered date:31/12/2008
Voriconazole versus Micafungin for empirical antifungal therapy in patients with neutropenia and persistent fever
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | febril neutropenia |
| Date of first enrollment | 2007/02/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Micafugin150mg iv once a day Voriconazole 6mg/kg iv twice a day on day1,followed by 4mg/kg iv twice daily |
Outcome(s)
| Primary Outcome | defervesce and survival rate after two and four weeks from starting treatment |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)AST/ALT/total bilirubin>5 times the upper limit of normal(at each institution).2)Karnofsky score<30%.3)Documented invasive fungal infection before starting treatment.4)History of treatment by voriconazole or mycafungin.5)History of allergy or hypersensitivity to voriconazole or mycafungin.6)Not eligible for the study in the opinion of investigators |
Related Information
| Primary Sponsor | Division of hematology,Iwate medical unversity |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Division of hematology,Iwate medical unversity |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 019-651-5111 |
| Affiliation | Iwate Medical unversity Hematology |
| scientific contact | |
| Name | Yoji Ishida |
| Address | 19-1 utimaru morioka Iwate Janpan Japan |
| Telephone | |
| Affiliation | Iwate Medical unversity Hematology |