A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis

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

Timeline

Start

2026-11-01

Primary completion

2029-12-01

Completion

2029-12-31

Publications

• Background REFERENCES Sehgal, I. S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2026). Post-tuberculosis lung disease and pulmonary aspergillosis management: challenges and considerations. Expert Rev Anti Infect Ther, 1-21. doi:10.1080/14787210.2026.2631525 Sehgal, I. S., Soundappan, K., Agarwal, R., Muthu, V., Dhooria, S., Prasad, K. T., . . . Chakrabarti, A. (2025). Prevalence of Chronic Pulmonary Aspergillosis in Patients With Mycobacterial and Non-Mycobacterial Tuberculosis Infection of the Lung: A Systematic Review and Meta-Analysis. Mycoses, 68(4), e70060. doi:10.1111/myc.70060 Sehgal, I. S., Agarwal, R., Dhooria, S., Prasad, K. T., Muthu, V., Aggarwal, A. N., . . . Chakrabarti, A. (2026). Oral itraconazole versus oral voriconazole for treatment-naive patients with chronic pulmonary aspergillosis in India (VICTOR-CPA trial): a single-centre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis, 26(3), 239-249. doi:10.1016/S1473-3099(25)00537-7 Sehgal, I. S., Dhooria, S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2024). Burden, clinical features, and outcomes of post-tuberculosis chronic obstructive lung diseases. Curr Opin Pulm Med, 30(2), 156-166. doi:10.1097/MCP.0000000000001026 Sehgal, I. S., Dhooria, S., Muthu, V., Prasad, K. T., Aggarwal, A. N., Chakrabarti, A., . . . Agarwal, R. (2022). Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India. Lancet Infect Dis, 22(7), 1052-1061. doi:10.1016/S1473-3099(22)00057-3 Ashbee, H. R., Barnes, R. A., Johnson, E. M., Richardson, M. D., Gorton, R., & Hope, W. W. (2014). Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother, 69(5), 1162-1176. doi:10.1093/jac/dkt508 Soundappan, K., Sehgal, I. S., Prabhakar, N., Rana, S., Raju, R., Dhooria, S., . . . Agarwal, R. (2024). Incidence and prevalence of ch

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