Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
Recruiting
Phase 3
Interventional Study
Chronic Pulmonary Aspergillosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 224 (estimated)
- Sponsor
- Poitiers University Hospital · Other
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About This Trial
This study compares the therapeutic (clinical and radiological) efficacy of a six-month treatment by itraconazole and nebulised Ambisome® (liposomal amphotericin B = LAmB) versus treatment by itraconazole alone, in non - or mildly - immunocompromised patients affected by Chronic Pulmonary Aspergillosis (single aspergilloma excluded).
• Control arm: Itraconazole 200 mg x 2/day associated with inac…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
All adult patients affected with Chronic Pulmonary Aspergillosis (CPA) "de novo" or in relapse (without any history of resistance to itraconazole) combining the following criteria are eligible:
1. Patient with an Aspergillus bronchopulmonary infection, be it cavitary, fibrotic,…
Contacts