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

Abstract

This multi-center, randomized, parallel-group, double-blind, double-dummy study compared the efficacy and safety of chlorproguanil–dapsone–artesunate (CDA) and chlorproguanil–dapsone (CPG–DDS) in the treatment of falciparum malaria in Africa (Burkina Faso, Ghana, Mali, Nigeria). Six hundred patients (≥ 1 year of age) received CDA 2.0/2.5/4.0 mg/kg, and 292 CPG–DDS 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–DDS, 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 ≥40 g/L or ≥40% versus baseline, haemoglobin

Citation

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

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

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