A Randomized Controlled Trial of Amphotericin B Versus Posaconazole for Treating Pulmonary Mucormycosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
Postgraduate Institute of Medical Education and Research
RECRUITING
Chandigarh
Contact Information
Primary
Valliappan Muthu
muthu.valliappan@pgimer.edu.in
+917087001389
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 50
Treatments
Active_comparator: Amphotericin B arm (standard of care)
Intravenous liposomal amphotericin B \[5 mg/kg per day\] for at least 4 weeks followed by maintenance therapy. Maintenance therapy (after four weeks of treatment initiation) will be continued for at least 12 weeks or longer as decided by the treating physician. The maintenance therapy will be posaconazole. However, if therapeutic drug monitoring is not possible or the participants opt to use isavuconazole or amphotericin, the same will be permitted and noted
Experimental: Posaconazole arm
Combination of liposomal amphotericin B (5 mg/kg per day) and posaconazole for first 7 days followed by oral posaconazole only (for induction as well as maintenance therapy). The first four weeks of therapy will be called induction therapy
Related Therapeutic Areas
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov