624
Participants
Start Date
September 30, 2007
Primary Completion Date
August 31, 2009
Study Completion Date
February 28, 2010
amphotericin B deoxycholate
Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions
Liposomal Amphotericin B with Miltefosine
Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or \> 25 kg Miltefosine 50 mg once daily if patient weighs \<25 mg
Liposomal Amphotericin B and Paromomycin Sulfate
AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11
miltefosine + Paromomycin sulfate
oral miltefosine 50mg once daily (\< 25 kg body weight) or twice daily ( \> 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days
Kala-azar Medical Research Center, Muzaffarpur
Drugs for Neglected Diseases
OTHER
Rajendra Memorial Research Institute of Medical Sciences
OTHER
Banaras Hindu University
OTHER