Posaconazole Delayed Release Oral Tablet: Posaconazole 300 mg will be given once daily
Itraconazole (ITZ): Itraconazole suprabioavailable will be given 130 mg twice daily
Study 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
Eligibility
Sex
ALL
Min age
12 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* One or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, fever, dyspnoea) for ≥3 months
* Slowly progressive or persistent radiological findings on CT thorax including one or more cavities with or without a fungal ball, fibrosis, pericavitary infiltrates, consolidation, nodules, or pleural thickening
* Serum A. fumigatus-IgG ≥27 milligrams of antibody/litre (mgA/L), or growth of Aspergillus in respiratory secretions (twice in sputum or once in bronchoalveolar lavage fluid \[BALF\]) or serum galactomannan index (GMI) ≥1.7 or BALF GMI ≥2.6.
* Exclusion of other pulmonary disorders with similar presentation (active pulmonary TB, malignancy, other infections)
Exclusion Criteria:
* Failure or refusal to provide written informed consent
* Patients on immunosuppressive drugs, receiving prednisolone (or equivalent) ≥10 mg/day for ≥3 weeks, or known HIV infection
* Intake of antifungal triazoles for ≥3 weeks in the preceding 3 months (prior azole therapy)
* Active pulmonary infection due to Mycobacterium tuberculosis or non-tuberculous mycobacteria
* Other forms of pulmonary aspergillosis (subacute or acute invasive aspergillosis)
* Pregnancy or lactation
* Significant hepatic dysfunction (ALT/AST ≥3× upper limit of normal at baseline)
* Known hypersensitivity to azole antifungals
Primary outcome measure(s)
Overall favorable treatment response at 12 months — 12 months Defined by: (1) Clinical improvement or stability; (2) Radiological improvement or stability on chest CT; and (3) No requirement for antifungal modification because of treatment failure.
Trial sites (2)
Facility
City
Region
Status
Chest Clinic, PGIMER, Chandigarh
Chandigarh
Chandigarh
Chest Clinic, PGIMER, Chandigarh
Chandigarh
Chandigarh
More Post Graduate Institute of Medical Education and Research, Chandigarh trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.