| 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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MedLine Citation:
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PMID: 19996424 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 (>or= 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 hemoglobin safety endpoint (hemoglobin drop >or= 40 g/L or >or= 40% versus baseline, hemoglobin < 50 g/L, or blood transfusion) were CDA 13/44 (30%), CPG-DDS 7/24 (29%) in G6PD-deficient patients versus CDA 4/448 (< 1%), CPG-DDS 6/221 (3%) in G6PD-normal patients. No deaths occurred. CDA was more efficacious than CPG-DDS. However, the hemolytic potential in G6PD-deficient patients does not support further development of CDA. |
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Authors:
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Alfred B Tiono; Alassane Dicko; Dennis A Ndububa; Tsiri Agbenyega; Simon Pitmang; Jacob Awobusuyi; Allan Pamba; Stephan Duparc; Li-Ean Goh; Emma Harrell; Nick Carter; Stephen A Ward; Brian Greenwood; Peter A Winstanley |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The American journal of tropical medicine and hygiene Volume: 81 ISSN: 1476-1645 ISO Abbreviation: Am. J. Trop. Med. Hyg. Publication Date: 2009 Dec |
Date Detail:
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Created Date: 2009-12-09 Completed Date: 2010-01-05 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0370507 Medline TA: Am J Trop Med Hyg Country: United States |
Other Details:
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Languages: eng Pagination: 969-78 Citation Subset: AIM; IM |
Affiliation:
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Centre National de Recherche et de Formation sur le Paludisme, Minist??re de la Sant??, Ouagadougou, Burkina Faso. t.alfred@fasonet.bf |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Africa South of the Sahara / epidemiology Animals Antimalarials / administration & dosage, therapeutic use* Artemisinins / administration & dosage, therapeutic use* Child Child, Preschool Chloroguanide / administration & dosage, adverse effects, analogs & derivatives*, therapeutic use Dapsone / administration & dosage, adverse effects, therapeutic use* Double-Blind Method Drug Therapy, Combination Female Glycogen Storage Disease Type I / genetics Hemolysis Humans Malaria, Falciparum / drug therapy* Male Plasmodium falciparum / genetics Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Antimalarials; 0/Artemisinins; 500-92-5/Chloroguanide; 537-21-3/chlorproguanil; 80-08-0/Dapsone; 83507-69-1/artesunate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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