drugset / Trial / NCT01074905
Study on the Treatment of Vivax Malaria
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.
Timeline
- Start
- 2010-05
- Primary completion
- 2012-10
- Completion
- 2012-10
Publications
- Stadler E, Cromer D, Mehra S, Adekunle AI, Flegg JA, Anstey NM, Watson JA, Chu CS, Mueller I, Robinson LJ, Schlub TE, Davenport MP, Khoury DS. Population heterogeneity in Plasmodium vivax relapse risk. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010990. doi: 10.1371/journal.pntd.0010990. eCollection 2022 Dec.
- Chu CS, Phyo AP, Lwin KM, Win HH, San T, Aung AA, Raksapraidee R, Carrara VI, Bancone G, Watson J, Moore KA, Wiladphaingern J, Proux S, Sriprawat K, Winterberg M, Cheah PY, Chue AL, Tarning J, Imwong M, Nosten F, White NJ. Comparison of the Cumulative Efficacy and Safety of Chloroquine, Artesunate, and Chloroquine-Primaquine in Plasmodium vivax Malaria. Clin Infect Dis. 2018 Oct 30;67(10):1543-1549. doi: 10.1093/cid/ciy319.
- Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Closing the translation gap for justice requirements in international research. J Med Ethics. 2012 Sep;38(9):552-8. doi: 10.1136/medethics-2011-100301. Epub 2012 Mar 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artesunate | Small molecule | 2 mg/kg | — |
| Subject | Chloroquine | Small molecule | 25 mg/kg | — |
| Subject | Primaquine | Small molecule | 0.5 mg/kg | — |