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DC Field | Value | Language |
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dc.contributor.author | Premji, Zul | - |
dc.contributor.author | Umeh, Rich E | - |
dc.contributor.author | Owusu-Agyei, Seth | - |
dc.contributor.author | Esamai, Fabian | - |
dc.contributor.author | Ezedinachi, Emmanuel U | - |
dc.contributor.author | Oguche, Stephen | - |
dc.contributor.author | Borrmann, Steffen | - |
dc.contributor.author | Sowunmi, Akintunde | - |
dc.contributor.author | Duparc, Stephan | - |
dc.contributor.author | Kirby, Paula L | - |
dc.contributor.author | Pamba, Allan | - |
dc.contributor.author | Kellam, Lynda | - |
dc.contributor.author | Guiguemde, Robert | - |
dc.contributor.author | Greenwood, Brian | - |
dc.contributor.author | Ward, Stephen A | - |
dc.contributor.author | Winstanley, Peter A | - |
dc.date.accessioned | 2022-11-07T12:16:02Z | - |
dc.date.available | 2022-11-07T12:16:02Z | - |
dc.date.issued | 2019-08-19 | - |
dc.identifier.uri | http://ir.mu.ac.ke:8080/jspui/handle/123456789/7035 | - |
dc.description.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 hematological safety in glucose-6-phosphate dehydrogenase (G6PD) -deficient patients.Methods and Findings: The trial was conducted at medical centers at 11 sites in five African countries between June 2006 and August 2007. 1372 patients ($1 to ,15 years old, median age 3 years) with acute uncomplicated 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, 20.9). CDA was non-inferior to AL, but there was simultaneous superiority of AL (upper 95%CI limit ,0). Adequate clinical and parasitological response at Day 28 (uncorrected for reinfection) was 79% (604/765) with CDA and 83% (315/381) with AL. In patients with a G6PD-deficient genotype (94/603 [16%] hemizygous males, 22/598 [4%] homozygous females), CDA had the propensity to cause severe and clinically concerning hemoglobin decreases: the mean hemoglobin nadir was 75 g/L (95%CI 71, 79) at Day 7 versus 97 g/L (95%CI 91, 102) for AL. There were three deaths, unrelated to study medication (two with CDA, one with AL).Conclusions: Although parasitologically effective at Day 28, the hemolytic potential of CDA in G6PD-deficient patients makes it unsuitable for use in a public health setting in Africa. | en_US |
dc.language.iso | en | en_US |
dc.publisher | PLOS ONE | en_US |
dc.subject | Chlorproguanil-dapsone-artesunate | en_US |
dc.subject | A randomized, double-blind | en_US |
dc.subject | Fixed-dose artemisinin- based combination therapy | en_US |
dc.title | Chlorproguanil-dapsone-artesunate versus artemether-lumefantrine: A randomized, double-blindphase III trial in african children and adolescents with uncomplicated plasmodium falciparum malaria | en_US |
dc.type | Article | en_US |
Appears in Collections: | School of Medicine |
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FABIAN 4.pdf | 405.97 kB | Adobe PDF | View/Open |
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