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

Abstract

Background: Chlorproguanil-dapsone-artesunate (CDA) was developed as an affordable, simple, fixed-dose artemisinin-based combination therapy for use in Africa. This trial was a randomized parallel-group, double-blind, double-dummy study to compare CDA and artemether-lumefantrine (AL) efficacy in uncomplicated Plasmodium falciparum malaria and further define the CDA safety profile, particularly its haematological safety in glucose-6-phosphate dehydrogenase (G6PD) -deficient patients. Methods and Findings: The trial was conducted at medical centres at 11 sites in five African countries between June 2006 and August 2007. 1372 patients (≥1 to P. falciparum malaria were randomized (2:1) to receive CDA 2/2.5/4 mg/kg once daily for three days (N = 914) or six-doses of AL over three days (N = 458). Non-inferiority of CDA versus AL for efficacy was evaluated in the Day 28 per-protocol (PP) population using parasitological cure (polymerase chain reaction [PCR]-corrected). Cure rates were 94.1% (703/747) for CDA and 97.4% (369/379) for AL (treatment difference –3.3%, 95%CI –5.6, -0.9). CDA was non-inferior to AL, but there was simultaneous superiority of AL (upper 95%CI limit

Citation

Duparc, S.; Esamai, F.; Ezedinachi, E.U.; Greenwood, B.; Guiguemdé, R.; Kellam, L.; Kirby, P.L.; Oguche, S.; Borrmann, S.; Sowunmi, A.; Owusu-Agyei, S.; Pamba, A.; Premji, Z.; Umeh, R.E.; Ward, S.A; Winstanley, P.A. Chlorproguanil-Dapsone-Artesunate versus Artemether-Lumefantrine: A Randomized, Double-Blind Phase III Trial in African Children and Adolescents with Uncomplicated Plasmodium falciparum Malaria. PLoS ONE (2009) 4 (8) e6682. [DOI: 10.1371/journal.pone.0006682]

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

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.