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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Summary
A prospective, randomized, open-label comparative study evaluating oral itraconazole and oral posaconazole in treatment-naïve patients with CPA, with treatment for 12 months is proposed. The study will compare clinical effectiveness and safety of the study drugs. The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
Official title: Optimizing Azole Therapy in Chronic Pulmonary Aspergillosis: A Randomized Comparative Study of Itraconazole and Posaconazole Integrating Clinical Outcomes, Azole Exposure, and Resistance Surveillance
Key Details
Gender
All
Age Range
12 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2026-11-01
Completion Date
2029-12-31
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
Posaconazole Delayed Release Oral Tablet
Posaconazole 300 mg will be given once daily
Itraconazole (ITZ)
Itraconazole suprabioavailable will be given 130 mg twice daily
Locations (2)
Chest Clinic, PGIMER, Chandigarh
Chandigarh, Chandigarh, India
Chest Clinic, PGIMER, Chandigarh
Chandigarh, Chandigarh, India