drugset / Trial / NCT05468372

Amphotericin Versus Posaconazole for Pulmonary Mucormycosis

NCT05468372

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-07-01
Primary completion
2026-02-01
Completion
2026-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 5 mg/kg Intravenous
Subject Posaconazole Small molecule 300 mg Oral