Status:
COMPLETED
A Randomized Controlled Trial to Compare the Clinical Outcomes With Six Months of Therapy With Oral Itraconazole Versus Oral Voriconazole for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Chronic Pulmonary Aspergillosis
Eligibility:
All Genders
13-90 years
Phase:
PHASE3
Brief Summary
The current initial therapy for CPA is with six months of oral itraconazole. However, the response with six months of therapy has a response rate of 65-70% and has a relapse rate after stopping treatm...
Detailed Description
Aspergillus is a saprophytic fungus which is present normally in our surroundings and causes a large number of pulmonary diseases spreading through inhalational route. The spectrum of disease caused b...
Eligibility Criteria
Inclusion
- The cases will include treatment naïve consecutive subjects with chronic cavitary pulmonary aspergillosis (CPA). The diagnosis of CPA will be made by a multidisciplinary team (pulmonary physicians, radiologist and microbiologist) based on composite of clinical, radiological and microbiological criteria.(9, 10) This includes presence of all the following: (i) one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months; (ii) slowly progressive or persistent radiological findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax; (iii) immunological (A.fumigatus-specific IgG \>27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index \>0.6 or BALF galactomannan index \>1.4); and, (iv) exclusion of other pulmonary disorders with similar presentation.
Exclusion
- Subjects with any of the following will be excluded: (i) failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of prednisolone (or equivalent) \>10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome; (iii) intake antifungal azoles for \>3 weeks in the preceding six months; (iv) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (v) subjects with others forms of pulmonary aspergillosis (allergic bronchopulmonary aspergillosis, chronic necrotizing aspergillosis and angio-invasive aspergillosis); and, (vi) pregnancy.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04824417
Start Date
March 1 2021
End Date
May 31 2024
Last Update
August 14 2024
Active Locations (2)
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1
Chest clinic
Chandigarh, India, 160012
2
Respiratory ICU, Department of Pulmonary Medicine, PGIMER
Chandigarh, India, 160012