Document Detail


Chlorproguanil-dapsone-artesunate versus chlorproguanil-dapsone: a randomized, double-blind, phase III trial in African children, adolescents, and adults with uncomplicated Plasmodium falciparum malaria.
MedLine Citation:
PMID:  19996424     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
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:
Created Date:  2009-12-09     Completed Date:  2010-01-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370507     Medline TA:  Am J Trop Med Hyg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  969-78     Citation Subset:  AIM; IM    
Affiliation:
Centre National de Recherche et de Formation sur le Paludisme, Minist??re de la Sant??, Ouagadougou, Burkina Faso. t.alfred@fasonet.bf
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MeSH Terms
Descriptor/Qualifier:
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:
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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