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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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Tiono, A. B., Dicko, A., Ndububa, D. A., Agbenyega, T., Pitmang, S., Awobusuyi, J., Pamba, A., Duparc, S., Goh, L.-E., Harrell, E., Carter, N., Ward, S. A., Greenwood, B. and Winstanley, Peter (2009) Chlorproguanil-Dapsone-Artesunate versus Chlorproguanil-Dapsone : a randomized, double-blind, phase III trial in African children, adolescents, and adults with uncomplicated plasmodium falciparum malaria. American Journal of Tropical Medicine and Hygiene, Vol.81 (No.6). pp. 969-978. doi:10.4269/ajtmh.2009.09-0351 ISSN 0002-9637.
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Official URL: http://dx.doi.org/10.4269/ajtmh.2009.09-0351
Abstract
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 (≥ 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 ≥ 40 g/L 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.
Item Type: | Journal Article | ||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | American Journal of Tropical Medicine and Hygiene | ||||
Publisher: | American Society of Tropical Medicine and Hygiene | ||||
ISSN: | 0002-9637 | ||||
Official Date: | 2009 | ||||
Dates: |
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Volume: | Vol.81 | ||||
Number: | No.6 | ||||
Page Range: | pp. 969-978 | ||||
DOI: | 10.4269/ajtmh.2009.09-0351 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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