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Recruiting Phase 2 NCT06794554

Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options

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Trial Parameters

Condition Chronic Pulmonary Aspergillosis
Sponsor Mundipharma Research Limited
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-30
Completion 2026-06-30
Interventions
Rezafungin Acetate

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Brief Summary

The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options. The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging. Participants will: * Be given the drug rezafungin every week for 6 months. * Visit the clinic once a month for checkups and tests. * Complete questionnaires on thier health and wellbeing.

Eligibility Criteria

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Males or females ≥18 years of age 3. Established diagnosis of CPA according to ESCMID/ERS criteria (2016) which includes all the following, which should be present for ≥3 months: * one or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, night sweats, fever and dyspnoea) * 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 * immunological, microbiological or molecular evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index \>0.5 or BALF galactomannan index \>1), positive Aspergillus IgG, or positive PCR * exclusion of active tuberculosis or non-tuberculous mycobacterial pulmonary infection or disorders that will prevent evaluation of o

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