drugset / Trial / NCT00941785
Dihydroartemisinin (DHA)-Piperaquine for IPT to Prevent Malaria in Children in Burkina Faso
Phase 2/3
Completed
1500 enrolled
London School of Hygiene and Tropical Medicine
BEIJING HOLLEY-COTEC PHARMACEUTICALS CO. LTD. · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The aim of the study is to determine whether piperaquine plus dihydroartemisinin (DHA-PQ) is as effective, and better tolerated, than sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ), when used for seasonal Intermittent Preventive Treatment (IPT) to prevent malaria in children aged 3 to 59 months in Bobo-Dioulasso, Burkina Faso and to determine the pharmacokinetics of piperaquine in children.
Timeline
- Start
- 2009-07
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Zongo I, Milligan P, Compaore YD, Some AF, Greenwood B, Tarning J, Rosenthal PJ, Sutherland C, Nosten F, Ouedraogo JB. Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso. Antimicrob Agents Chemother. 2015 Aug;59(8):4387-96. doi: 10.1128/AAC.04923-14. Epub 2015 Apr 27.
- Some AF, Zongo I, Compaore YD, Sakande S, Nosten F, Ouedraogo JB, Rosenthal PJ. Selection of drug resistance-mediating Plasmodium falciparum genetic polymorphisms by seasonal malaria chemoprevention in Burkina Faso. Antimicrob Agents Chemother. 2014 Jul;58(7):3660-5. doi: 10.1128/AAC.02406-14. Epub 2014 Apr 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 2.1 mg/kg | — |
| Comparator | amodiaquine | Other / unclassified | 10 mg/kg | — |
| Subject | piperaquine | Small molecule | 16.8 mg/kg | — |
| Comparator | pyrimethamine | Small molecule | 1.25 mg/kg | — |
| Comparator | sulfadoxine | Small molecule | 25 mg/kg | — |