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CPAAARI-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
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517004-11-00
Acronym
CPAAARI
Enrollment
224
Registered
2024-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pulmonary aspergillosis

Brief summary

Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement.

Detailed description

-Clinical evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or clinical deterioration./-Radiological evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or deterioration, -Major events during the 24-months follow-up period after stopping study treatment (i.e.; between visit M6 (at 6 months) and visit M30 (at 30 months)., Relapse during the 24-months follow-up period after stopping study treatment (between visits M6 and M30)., Mycological response after 3 and 6 months of study treatment., Number of medical consultations or hospitalizations for respiratory symptoms during the 6-month study treatment and the 24-month follow-up period, Clinical and biological tolerance, Improvement in quality of life evaluated by the VQ-11 Questionnaire, Concordance evaluation assessment between parameters for CPA diagnosis and evolution (see ancillary project annex 3 of this protocol)

Interventions

DRUGVFEND 200 mg film-coated tablets
DRUG9 %
DRUGsolution injectable
DRUGSALBUTAMOL
DRUGSPORANOX 100 mg capsule rigide
DRUGNoxafil 100 mg gastro-resistant tablets
DRUGAmBisome liposomal 50 mg Pulver zur Herstellung einer Infusionsdispersion

Sponsors

Centre Hospitalier Universitaire De Poitiers
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Therapeutic efficacy at 6 months is a composite criterion defined by the association of clinical improvement/stability and radiological improvement.

Secondary

MeasureTime frame
-Clinical evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or clinical deterioration./-Radiological evolution after 3 or 6 months: patient will be classified in one of 3 classes: improvement or stability or deterioration, -Major events during the 24-months follow-up period after stopping study treatment (i.e.; between visit M6 (at 6 months) and visit M30 (at 30 months)., Relapse during the 24-months follow-up period after stopping study treatment (between visits M6 and M30)., Mycological response after 3 and 6 months of study treatment., Number of medical consultations or hospitalizations for respiratory symptoms during the 6-month study treatment and the 24-month follow-up period, Clinical and biological tolerance, Improvement in quality of life evaluated by the VQ-11 Questionnaire, Concordance evaluation assessment between parameters for CPA diagnosis and evolution (see ancillary project annex 3 of this protocol)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026