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

• Status: Recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

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 treatment of up to 50%. Voriconazole is a third-generation azole and a theoretical advantage of lower MICs compared to itraconazole. Also, oral voriconazole has good availability (95%) in fasting state. This is likely to improve the response rate and reduce the chances of relapse of chronic pulmonary aspergillosis. There is no head to head comparison of oral itraconazole with oral voriconazole. In this study we intent 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Itraconazole; Voriconazole

Criteria

Inclusion Criteria:

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 Criteria:

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.