drugset / Trial / NCT01624337
Malaria Prevention Cambodia
Terminated
231 enrolled
Armed Forces Research Institute of Medical Sciences, Thailand
National Centre for Parasitology, Entomology and Malaria Control, Cambodia · collabRoyal Cambodian Armed Forces · collabUnited States Army Medical Materiel Development Activity · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
Timeline
- Start
- 2012-05
- Primary completion
- 2014-08
- Completion
- 2015-06
Outcome
Outcome not reported
Stopped: “Medication safety concern”
Publications
- Background Manning J, Vanachayangkul P, Lon C, Spring M, So M, Sea D, Se Y, Somethy S, Phann ST, Chann S, Sriwichai S, Buathong N, Kuntawunginn W, Mitprasat M, Siripokasupkul R, Teja-Isavadharm P, Soh E, Timmermans A, Lanteri C, Kaewkungwal J, Auayporn M, Tang D, Chour CM, Prom S, Haigney M, Cantilena L, Saunders D. Randomized, double-blind, placebo-controlled clinical trial of a two-day regimen of dihydroartemisinin-piperaquine for malaria prevention halted for concern over prolonged corrected QT interval. Antimicrob Agents Chemother. 2014 Oct;58(10):6056-67. doi: 10.1128/AAC.02667-14. Epub 2014 Aug 4.
- Vanachayangkul P, Lon C, Spring M, Sok S, Ta-Aksorn W, Kodchakorn C, Pann ST, Chann S, Ittiverakul M, Sriwichai S, Buathong N, Kuntawunginn W, So M, Youdaline T, Milner E, Wojnarski M, Lanteri C, Manning J, Prom S, Haigney M, Cantilena L, Saunders D. Piperaquine Population Pharmacokinetics and Cardiac Safety in Cambodia. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02000-16. doi: 10.1128/AAC.02000-16. Print 2017 May.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 180 mg | — |
| Subject | piperaquine | Small molecule | 1440 mg | — |