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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

October 30, 2021

Study Completion Date

December 30, 2021

Conditions
Pulmonary Mucormycosis
Interventions
DRUG

Inhaled amp B deoxycholate+intravenous liposomal amp B

"Intravenous liposomal amphotericin B (beginning with 3mg/kg) along with inhaled amphotericin as below: Amp-B deoxycholate 50 mg (Amphotret™ Bharat serums and vaccines limited), will be dissolved in 10 mL distilled water. 2 mL of the reconstituted amphotericin B solution will be transferred into the drug chamber of a breath actuated nebulizer (Lupineb Ultra kit breath actuated nebulize which contains aeroclipse XL Reusable Breath Actuated Nebulizer and DeVilbiss 3655 compressor). 3 mL of distilled water is added to 2 mL of the reconstituted amphotericin B. The nebulization is continued till the chamber is emptied of the drug or the patient does not tolerate the therapy.~The first three doses of amphotericin B nebulization will be under the direct supervision of a physician. If tolerated, nebulization will be continued twice a day till tolerated or till response.The patient will complete a VAS score for cough after nebulization."

DRUG

Intravenous liposomal amphotericin B alone

Intravenous liposomal amphotericin B (beginning with 3mg/kg, up to 5 mg/kg), with or without surgery or other antifungals as clinically indicated

Trial Locations (1)

160012

Post graduate Institute medical education and research, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT04502381 - Combined Inhalational With Intravenous Amphotericin B Versus Intravenous Amphotericin B Alone for Pulmonary Mucormycosis | Biotech Hunter | Biotech Hunter