Chlorproguanil-Dapsone-Artesunate versus Chlorproguanil-Dapsone: A Randomized, Double-Blind, Phase III Trial in African Children, Adolescents, and Adults with Uncomplicated Plasmodium falciparum Malaria

From:
Foreign, Commonwealth & Development Office
Published
1 January 2009
Country:
Ghana, Nigeria, Mali and Burkina Faso
Document Type:
Journal Article
Theme:
Health
First published:
1 January 2009
Authors:
Greenwood, B., Agbenyega, T., Tiono, A.B., Duparc, S. and Awobusuyi, J.
Show 9 more
Carter, N., Dicko, A., Goh, L.E., Harrell, E., Ndububa, D.A., Pamba, A., Pitmang, S., Ward, S.A., and Winstanley, P.A.

Abstract

This multi-center, randomized, parallel-group, double-blind, double-dummy study compared the efficacy and safety of chlorproguanil鈥揹apsone鈥揳rtesunate (CDA) and chlorproguanil鈥揹apsone (CPG鈥揇DS) in the treatment of falciparum malaria in Africa (Burkina Faso, Ghana, Mali, Nigeria). Six hundred patients (鈮� 1 year of age) received CDA 2.0/2.5/4.0 mg/kg, and 292 CPG鈥揇DS 2.0/2.5 mg/kg, once daily for 3 days. Day 28 parasitologic cure rate (polymerase chain reaction [PCR]-corrected, per-protocol population) was 89.1% (416/467) for CDA, non-inferior but also superior to CPG鈥揇DS, 83.0% (176/212) (treatment difference 6.1%; 95% confidence interval [CI] 0.3, 11.9). Glucose-6-phosphate dehydrogenase (G6PD) genotype was available for 844/892 (95%) patients. Occurrences of a composite haemoglobin safety endpoint (haemoglobin drop 鈮�40 g/L or 鈮�40% versus baseline, haemoglobin

Citation

American Journal of Tropical Medicine and Hygiene (2009) 81 (6) 969-978 [doi:10.4269/ajtmh.2009.09-0351]

Updates to this page

Published 1 January 2009
Contents