A single high dose treatment of kala-azar with Ambisome (amphotericin B lipid complex): a pilot study.

Thirty four patients with parasitologically confirmed visceral leishmaniasis were divided randomly into two groups of 17. Group A received Ambisome (amphotericin B lipid complex) at a dose of 15mg/kg body weight infused over 2h as a single dose; patients in group B received amphotericin B deoxycholate at a dose of 1mg/kg body infused for 2h for 20days. All 34 patients had a clinical, parasitological and ultimate cure. Ambisome was much better tolerated than amphotericin B, and adverse events were fewer in the Ambisome group. It was concluded that, if the cost of Ambisome were reduced, it would be a suitable first line drug. A longer study comparing three regimes of Ambisome: 15mg/kg body weight, 11mg/kg body weight and 7.5mg/kg body weight, should be undertaken.

RCT Entities:   Population Interventions Outcomes