A phase II dose-ranging study of sitamaquine for the treatment of visceral leishmaniasis in India

This randomized, open label, multicenter study assessed the dose-response and safety profile for oral sitamaquine in 120 Indian subjects with visceral leishmaniasis (VL). Patients aged 5-64 years (mean age 21.2 years) received one of four sitamaquine doses (1.5, 1.75, 2.0, or 2.5 mg kg(-1) day(-1))...

Full description

Saved in:

Bibliographic Details
Published in:	The American journal of tropical medicine and hygiene Vol. 73; no. 6; p. 1005
Main Authors:	Jha, Tara K, Sundar, Shyam, Thakur, Chandreshwar P, Felton, J Mark, Sabin, Antony J, Horton, John
Format:	Journal Article
Language:	English
Published:	United States 01-12-2005
Subjects:	Administration, Oral Adolescent Adult Aminoquinolines - administration & dosage Aminoquinolines - adverse effects Aminoquinolines - therapeutic use Antiprotozoal Agents - administration & dosage Antiprotozoal Agents - adverse effects Antiprotozoal Agents - therapeutic use Child Drug Administration Schedule Female Humans India Leishmaniasis, Visceral - drug therapy Leishmaniasis, Visceral - pathology Male Middle Aged Treatment Outcome India
Online Access:	Get more information
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	This randomized, open label, multicenter study assessed the dose-response and safety profile for oral sitamaquine in 120 Indian subjects with visceral leishmaniasis (VL). Patients aged 5-64 years (mean age 21.2 years) received one of four sitamaquine doses (1.5, 1.75, 2.0, or 2.5 mg kg(-1) day(-1)) daily for 28 days. At Day 180 in the intent-to-treat population, final cure (primary efficacy outcome) was achieved in 92 of 106 (87%) patients overall and 25 of 31 (81%), 24 of 27 (89%), 23 of 23 (100%), and 20 of 25 (80%) patients at doses of 1.5, 1.75, 2.0, or 2.5 mg kg(-1) day(-1) sitamaquine, respectively. Sitamaquine was generally well tolerated. The most common adverse events during the active treatment phase were vomiting (8% [10 of 120]), dyspepsia (8% [9 of 120]) and cyanosis (3% [4 of 120]). Nephrotic syndrome (3% [3 of 120]) and glomerulonephritis (2% [2 of 120]) were also reported and require further investigation. Oral sitamaquine demonstrated efficacy in Indian VL and was well tolerated.
ISSN:	0002-9637
DOI:	10.4269/ajtmh.2005.73.1005