Intravenous liposomal amphotericin B versus intravenous voriconazole for chronic pulmonary aspergillosis: a multicenter, open-labeled trial in Japan

UMIN ID: UMIN000002236

Registered date:22/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic pulmonary aspergillosis
• Date of first enrollment: 2009/07/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of antifungal drugs (liposomalamphotericin B)
Administration of antifungal drug (voriconazole)

Outcome(s)

• Primary Outcome: Improvement of clinical symptoms and radiological findings in chest X-ray and CT at the two weeks after the initiation of drugs and the end of the treatment.
• Secondary Outcome: Improvement of inflamatory markers and mycological findings at the two weeks after the initiation of the drugs and the end of the treatment.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The following patients are excluded from the study. #1. Patients who are going to be excluded due to the difficulty of determine efficacy. (1) patients received amphotericin B (AMPH-B), liposomal amphotericin B (L-AMB) or voriconazole (VRCZ) within a month at the time of the diagnosis of CPA, (2) patients received other antifungal drugs such as itraconazole, flucytosine, miconazole, fluconazole, nystatin or micafungin and have already started to being improved or with unknown medical course. (3) patients who are diagnosed other than CPA. #2. Patients who are going to be excluded due to the safety issues. (1) patients who fulfilled the contraindication of AMPH-B, L-AMB and VRCZ. (2) patients with liver, kidney and heart failure (more than Grade II in CTCAEv3.0). (3) pregnant or breast feeding patients, and patients who are willing to have baby. #3. Patients whom are considered to be excluded by the attending physicians with various reasons.

Related Information

• Primary Sponsor: NEOCI (Nagasaki Evaluation Organization for Clinical Interventions)
• Source(s) of Monetary Support: NEOCI (Nagasaki Evaluation Organization for Clinical Interventions)