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).

CHU DE POITIERS0 sites224 target enrollmentMarch 22, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: MedDRA version: 20.1 Level: LLT Classification code 10022881 Term: Invasive bronchopulmonary aspergillosis System Organ Class: 100000004862
Sponsor: CHU DE POITIERS
Enrollment: 224
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

March 22, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•All adult patients affected with 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 over at least 3 months of observation, be it cavitary, fibrotic or nodular and documented by compatible thoracic CT\-scan images \[8, 16];
•2\. Associated with one of the following criteria:
•\-documented anti\-Aspergillus IgG and/or precipitin antibodies,
•\-positive direct examination of Aspergillus or positive culture, from bronchopulmonary samples (expectoration or endoscopic aspiration),
•\-revealing aspergillar hyphae on histological analysis
•3\. Men or women age \= 18 years;
•4\. For the women of childbearing age: women having a negative serum pregnancy test, having a contraception highly effective and accepting to pursue it during at least the first 12 months of the study;
•5\. Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures;
•6\. Participants must be affiliated to France's Health Care Regime (« Sécurité Sociale »);

•1 \- Patient affected with single aspergilloma
•2 \- Patient presenting a contraindication to itraconazole (including contraindicated medications with potential to prolong the QT interval as listed in the itraconazole SmPC)
•3\- Patient presenting a contraindication to voriconazole or posaconazole
•4 – Intolerance to beta2\-agonists
•5 – Notion of resistance to itraconazole
•6 \- History of hypersensitivity reaction to liposomal amphotericin B or to itraconazole or to any other constituent
•7 \- Patient treated by nebulised LAmB during the previous month, or having presented complications related to a previous treatment by nebulised LAmB
•8 – Patient received an oral (excepted oral Amphotéricine B), parenteral or intra\-cavity antifungal treatment within the last 2 months
•9 \- Severe renal failure (clearance \<30 ml / min).
•10 \- Hepatic failure with transaminase and alkaline phosphatase values \> 5 times normal