Overview

Amphotericin Versus Posaconazole for Pulmonary Mucormycosis

Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research
Treatments:
Amphotericin B
Liposomal amphotericin B
Posaconazole
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