To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

Phase 3 Completed 500 enrolled Bharat Serums and Vaccines Limited Ministry of Science and Technology · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).

Timeline

Start: 2009-07
Primary completion: 2011-01
Completion: 2011-01

Publications

Sundar S, Pandey K, Thakur CP, Jha TK, Das VN, Verma N, Lal CS, Verma D, Alam S, Das P. Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study. PLoS Negl Trop Dis. 2014 Sep 18;8(9):e3169. doi: 10.1371/journal.pntd.0003169. eCollection 2014 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amphotericin B	Unknown	15 mg/kg	Other
Subject	Amphotericin B Lipid emulsion	Unknown	15 mg/kg	Other

To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

Summary

Timeline

Publications

Drugs

Indications