التفاصيل البيبلوغرافية
| العنوان: |
Chlorproguanil2Dapsone2Artesunate versus Artemether2Lumefantrine: A Randomized, Double-Blind Phase III Trial in African Children and Adolescents with Uncomplicated Plasmodium falciparum Malaria |
| المؤلفون: |
Premji, Zul, E. Umeh, Rich, Owusu-Agyei, Seth, Esamai, Fabian, l U. Ezedinachi, Emmanue, Oguche, Stephen, Borrmann, Steffen, Sowunmi, Akintunde, Duparc, Stephan, L. Kirby, Paula, Pamba, Allan, Kellam, Lynda, Guiguemde´, Robert, Greenwood, Brian, A. Ward, Stephen, A. Winstanley, Peter |
| بيانات النشر: |
PLOS ONE |
| سنة النشر: |
2009 |
| المجموعة: |
Moi University Repository |
| مصطلحات موضوعية: |
Chlorproguanil -Dapsone -Artesunate versus ArtemetherLumefantrine, Children and adolescents with uncomplicated Plasmodium falciparum Malaria |
| الوصف: |
ackground: Chlorproguanil2dapsone2artesunate (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 artemether2lumefantrine (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. ; (WHO TDR) |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| Relation: |
http://ir.mu.ac.ke:8080/jspui/handle/123456789/9092 |
| الاتاحة: |
http://ir.mu.ac.ke:8080/jspui/handle/123456789/9092 |
| رقم الانضمام: |
edsbas.F20FD98B |
| قاعدة البيانات: |
BASE |