drugset / Trial / NCT01743820
Phase2a Primaquine Dose Escalation Study
Phase 2
Completed
81 enrolled
University of California, San Francisco
Bill and Melinda Gates Foundation · collabMahidol Oxford Tropical Medicine Research Unit · collabMalaria Research and Training Center, Bamako, Mali · collabShoklo Malaria Research Unit · collabWellcome Trust · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
Timeline
- Start
- 2013-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Publications
- Background Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26.
- Background Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4.
- Background WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.
- Background WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization
- Background El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.
- Background Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1.
- Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Primaquine | Small molecule | 0.0625 mg/kg | Oral |
| Subject | Primaquine | Small molecule | 0.125 mg/kg | Oral |
| Subject | Primaquine | Small molecule | 0.25 mg/kg | Oral |
| Subject | Primaquine | Small molecule | 0.5 mg/kg | Oral |
| Background | ARTENIMOL | Small molecule | 320 mg | — |
| Background | piperaquine | Small molecule | 40 mg | — |