Amphotericin Versus Posaconazole for Pulmonary Mucormycosis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Enrolling; Phase 2

Conditions: Mucormycosis; Pulmonary (Etiology)

Treatments: Drug: Posaconazole 600 mg followed by posaconazole 300 mg once daily; Drug: Liposomal Amphotericin B

Study type: Interventional

Funder types: Other

Identifiers

NCT05468372

IEC-INT/2022/DM-262

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Amphotericin B arm (standard of care)

Active Comparator group

Description:

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

Treatment:

Drug: Liposomal Amphotericin B

Posaconazole arm

Experimental group

Description:

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

Treatment:

Drug: Liposomal Amphotericin B

Drug: Posaconazole 600 mg followed by posaconazole 300 mg once daily