UMIN ID: UMIN000001786
Registered date:19/03/2009
Intravenous micafungin versus intravenous voriconazole for chronic necrotizing pulmonary aspergillosis: a multicenter, open-labeled, non-inferiority trial in Japan
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic necrotizing pulmonary aspergillosis |
| Date of first enrollment | 2006/04/01 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Administration of antifungal drugs (MCFG) Administration of antifungal drugs (VRCZ) |
Outcome(s)
| Primary Outcome | Efficacy of drugs after administration of two weeks |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The following patients were excluded from the study: (1) patients received MCFG or VRCZ within a month at the time of the diagnosis of CNPA, (2) patients with simple aspergilloma, invasive pulmonary aspergillosis, or allergic bronchopulmonary aspergillosis, (3) patients with infectious diseases other than Aspergillosis, (4) pregnant patients, (5) patients without informed consent, and (6) patients with liver, kidney and heart failure (more than Grade II in CTCAEv3.0). |
Related Information
| Primary Sponsor | NEOCI (Nagasaki Evaluation Organization for CLinical Interventions) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | NEOCI (Nagasaki Evaluation Organization for CLinical Interventions) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Koichi Izumikawa |
| Address | Japan |
| Telephone | |
| koizumik@nagasaki-u.ac.jp | |
| Affiliation | Nagasaki University Graduate School of Biomedical Sciences Department of Molecular Microbiology and Immunology |
| scientific contact | |
| Name | Shigeru Kohno |
| Address | 1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN Japan |
| Telephone | |
| Affiliation | Nagasaki University Graduate School of Biomedical Sciences Department of Molecular Microbiology and Immunology |