Status:
COMPLETED
Voriconazole For Chronic Bronchopulmonary Aspergillosis
Lead Sponsor:
Pfizer
Conditions:
Aspergillosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00159822
Start Date
July 1 2005
End Date
December 1 2008
Last Update
January 20 2010
Active Locations (18)
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1
Pfizer Investigational Site
Nantes, Cedex, France, 44093
2
Pfizer Investigational Site
Angers, France, 49033
3
Pfizer Investigational Site
Bobigny, France, 93000
4
Pfizer Investigational Site
Brest, France, 29609