Amphotericin Versus Posaconazole for Pulmonary Mucormycosis

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

July 30, 2025

Conditions
Mucormycosis; Pulmonary (Etiology)
Interventions
DRUG

Posaconazole 600 mg followed by posaconazole 300 mg once daily

Posaconazole will be given as a delayed release tablet, the dose would be 600 mg in two divided doses on day 1, followed by 300 mg once a day from then on. If a subject vomits within 15 minutes of posaconazole tablet administration, the dosing should be repeated as soon as possible, following appropriate antiemetic treatment. The drug will be administered after a meal.

DRUG

Liposomal Amphotericin B

"All study subjects will be administered intravenous liposomal amphotericin B \[5 mg/kg/day infusion in 5% dextrose solution\] over at least 2 hours, as per recommendations. Amphotericin B will be administered for the first seven days in the experimental arm, whereas it will be administered atleast for four weeks in the active comparator arm. Premedication or intravenous hydration will not be routinely administered. For patients experiencing chills, fever, hypotension, nausea, or other non-anaphylactic immediate infusion-related reactions, premedication (acetaminophen, diphenhyramine or hydrocortisone) will be administered 30 to 60 minutes prior to the next dose of amphotericin infusion.~The dose of intravenous amphotericin B will be modified further if required, based on the tolerability, and response to treatment."

Trial Locations (1)

160012

RECRUITING

Postgraduate Institute of Medical Education and Research, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER