Chronic Pulmonary Aspergillosis and Ambisome Aerosol With Itraconazole
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
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 inactive nebulised treatment twice
a week during 24 weeks.
• Experimental arm: Itraconazole 200 mg x 2/day associated with nebulised LAmB, at 25 mg
twice a week during 24 weeks.
Follow up duration for the patients will be 24 months (12 months minimum) after
discontinuation of the treatment being studied.
Phase:
Phase 3
Details
Lead Sponsor:
Poitiers University Hospital
Treatments:
Amphotericin B Hydroxyitraconazole Itraconazole Liposomal amphotericin B