Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole
Therapeutic Efficacy Comparison of a Six-month Treatment by Itraconazole and Nebulised Ambisome® Versus Treatment by Itraconazole Alone in Non- or Mildly- Immunocompromised Patients with Chronic Pulmonary Aspergillosis: a Prospective, Randomized, Single Blind Study, (single Aspergilloma Excluded)
Poitiers University Hospital
224 participants
Dec 19, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
inhaled liposomal amphotericin B = inhaled LAmB
inhaled isotonic saline
Itraconazole tablet
Locations(1)
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NCT03656081