Actively Recruiting
Amphotericin Versus Posaconazole for Pulmonary Mucormycosis
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2024-09-27
50
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pulmonary mucormycosis is a serious illness with high morbidity and mortality (approximately 57%). Surgery and antifungal therapy are central in the management of mucormycosis. Unlike rhino-orbital mucormycosis, surgery is not feasible in several patients with pulmonary mucormycosis. Hence, treatment is primarily with antifungal therapy. Amphotericin B is the standard of care in the medical management of mucormycosis. However, amphotericin B is expensive, has significant adverse events, and is available only in parenteral formulation. Posaconazole is effective against Mucorales, and is currently approved for salvage therapy of mucormycosis. Recent evidence suggest that in several patients, posaconazole may be effective as a monotherapy upfront. In the current study posaconazole versus amphotericin B will be evaluated for the management of pulmonary mucormycosis in a randomized clinical trial.
CONDITIONS
Official Title
Amphotericin Versus Posaconazole for Pulmonary Mucormycosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with proven or probable pulmonary mucormycosis
- Participants with suspected pulmonary mucormycosis based on clinical presentation and compatible imaging
- Age 13 years or older
You will not qualify if you...
- Failure to provide informed consent
- Allergic or hypersensitive to amphotericin B, posaconazole, or their components
- Received more than 4 days of antifungal treatment before randomization
- Pregnant women
- High risk of death within 48 hours after enrollment
- Possible pulmonary mucormycosis not confirmed within four working days of enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
Research Team
V
Valliappan Muthu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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