Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 2

Conditions: Pulmonary Mucormycosis

Treatments: Drug: Inhaled amp B deoxycholate+intravenous liposomal amp B; Drug: Intravenous liposomal amphotericin B alone

Study type: Interventional

Funder types: Other

Identifiers

NCT04502381

NK/6146/DM/452

Details and patient eligibility

About

To assess the safety and feasibility of combined inhalational and intravenous amphotericin B therapy for the treatment of pulmonary mucormycosis. And compare the efficacy of combined therapy with that of intravenous amphotericin B alone.

Full description

Pulmonary mucormycosis is a relatively a rare disease with a high mortality. The angioinvasion associated with mucormycosis prevents efficient drug delivery at the diseased site. Inhaled amphotericin B achieves drug levels in lung tissue and has been shown to be useful in several diseases including chronic pulmonary and allergic bronchopulmonary aspergillosis. Further inhaled forms of amphotericin B are associated with less nephrotoxicity and other systemic adverse effects. The role of inhaled amphotericin B in pulmonary mucormycosis has been previously demonstrated in murine models and anecdotal reports. The study hypothesis is that combined therapy with inhalational and intravenous amphotericin B is likely to result in better outcomes as compared with intravenous amphotericin B alone for treatment of pulmonary mucormycosis

Enrollment: 30 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects with a clinicoradiologic suspicion of pulmonary mucormycosis will be enrolled if the diagnosis of mucormycosis is pathologically or microbiologically (smear showing aseptate hyphae, culture or molecular evidence showing Mucorales) confirmed. Cases of disseminated mucormycosis will be included, only if the pulmonary infection is confirmed pathologically or microbiologically from respiratory secretions or biopsy samples

Exclusion criteria

• Lack of informed consent
• Hypersensitivity to amphotericin B or any component of the formulation
• Pregnancy
• High likelihood of death within 48 h of enrolment
• Suspected pulmonary mucormycosis without histological or microbiologic proof

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention arm

Experimental group

Description:

The study participants in the intervention arm will receive nebulization with amphotericin B deoxycholate (10 mg twice a day every alternate day, as described below) along with intravenous liposomal amphotericin B (3 to 5 mg/kg body weight)

Treatment:

Drug: Intravenous liposomal amphotericin B alone

Drug: Inhaled amp B deoxycholate+intravenous liposomal amp B

Conventional arm

Active Comparator group

Description:

Participants will receive treatment with only intravenous liposomal amphotericin B (3 to 5 mg/kg body weight)

Treatment:

Drug: Intravenous liposomal amphotericin B alone