Voriconazole For Chronic Bronchopulmonary Aspergillosis

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Aspergillosis

Treatments: Drug: Voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00159822

A1501061

Details and patient eligibility

About

To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:
• Complex aspergilloma non primarily operable,
• Chronic necrotizing pulmonary aspergillosis,
• Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.

Exclusion criteria

• Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong QT interval, or prolongation of QTc interval > 450 msec in men and > 470 msec in women.
• Simple aspergilloma with primary indication of surgical treatment.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Voriconazole