Chronic Pulmonary Aspergillosis and Ambisome Aerosol With Itraconazole

Chronic Pulmonary Aspergillosis Clinical Trial

Official title:
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)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03656081
Study type	Interventional
Source	Poitiers University Hospital
Contact	Céline DELETAGE
Phone	+33 5 49 44 38 54
Email	celine.deletage@chu-poitiers.fr
Status	Recruiting
Phase	Phase 3
Start date	December 19, 2018
Completion date	December 2029

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