drugset / Trial / NCT00519467
Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum Malaria
RandomizedParallel-groupOpen-labelTreatment
Summary
Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria policy of using Artemisinin-based combination therapies (ACT), there is a need to develop new, safe, effective and affordable ACT. Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment of uncomplicated falciparum malaria in Africa.
Timeline
- Start
- 2003-06
- Primary completion
- 2005-02
- Completion
- 2005-02
Publications
- Miller AK, Bandyopadhyay N, Wootton DG, Duparc S, Kirby PL, Winstanley PA, Ward SA. Pharmacokinetics of chlorproguanil, dapsone, artesunate and their major metabolites in patients during treatment of acute uncomplicated Plasmodium falciparum malaria. Eur J Clin Pharmacol. 2009 Oct;65(10):977-87. doi: 10.1007/s00228-009-0672-1. Epub 2009 Jun 11.
- Wootton DG, Opara H, Biagini GA, Kanjala MK, Duparc S, Kirby PL, Woessner M, Neate C, Nyirenda M, Blencowe H, Dube-Mbeye Q, Kanyok T, Ward S, Molyneux M, Dunyo S, Winstanley PA. Open-label comparative clinical study of chlorproguanil-dapsone fixed dose combination (Lapdap) alone or with three different doses of artesunate for uncomplicated Plasmodium falciparum malaria. PLoS One. 2008 Mar 5;3(3):e1779. doi: 10.1371/journal.pone.0001779.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 1 mg/kg | — |
| Subject | Artesunate | Small molecule | 2 mg/kg | — |
| Subject | Artesunate | Small molecule | 4 mg/kg | — |
| Background | Dapsone | Small molecule | 2.5 mg/kg | — |
| Background | chlorproguanil | Small molecule | 2 mg/kg | — |