Comparing two antifungal treatments for pulmonary mucormycosis
A Randomized Controlled Trial of Amphotericin B Versus Posaconazole for Treating Pulmonary Mucormycosis
This study is testing whether a new antifungal medicine called posaconazole works better than the standard treatment, amphotericin B, for people with a serious fungal infection in their lungs.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh, Chandigarh) |
| Trial ID | NCT05468372 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of posaconazole versus amphotericin B in treating pulmonary mucormycosis, a severe fungal infection with high mortality rates. Participants diagnosed with proven or probable pulmonary mucormycosis will be randomly assigned to receive either posaconazole or liposomal amphotericin B. The study aims to determine if posaconazole can serve as an effective upfront monotherapy, potentially offering a safer and more accessible treatment option compared to the standard care. The trial will focus on assessing treatment outcomes and adverse events associated with each antifungal therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with proven or probable pulmonary mucormycosis.
Not a fit: Patients who have already received more than four days of antifungal treatment prior to randomization or those with high chances of mortality within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients suffering from pulmonary mucormycosis.
How similar studies have performed: While amphotericin B is the standard treatment, recent evidence suggests that posaconazole may be effective as an upfront therapy, indicating a novel approach that has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects with proven or probable pulmonary mucormycosis. Participants with a suspicion of pulmonary mucormycosis (as defined previously) based on compatible clinical presentation and compatible imaging will be screened for inclusion in the study. Exclusion Criteria: * Failure to provide informed consent * Contraindications or hypersensitivity to amphotericin B, posaconazole or their components * Already received \>4 days of antifungals prior to randomization into the study * Pregnant women * High chances of mortality within 48 hours of enrolment into the study Subjects with possible pulmonary mucormycosis will also be excluded, if their diagnosis is not confirmed within four working days of enrollment
Where this trial is running
Chandigarh, Chandigarh
- Postgraduate Institute of Medical Education and Research — Chandigarh, Chandigarh, India (Recruiting)
Study contacts
- Study coordinator: Valliappan Muthu
- Email: muthu.valliappan@pgimer.edu.in
- Phone: +917087001389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.