Study to Assess Efficacy of Artemether-lumefantrine Prophylaxis Against Forest Malaria in Cambodia (PAL_Cambodia)

Summary

In the Greater Mekong Subregion (GMS) adults are at highest risk for malaria. The most relevant disease vectors bite during daytime and outdoors which makes forest work a high-risk activity for malaria. The absence of effective vector control strategies and limited periods of exposure during forest visits suggest that chemoprophylaxis could be an appropriate strategy to protect forest workers against malaria. The investigators propose the use of Artemether-lumefantrine (AL), a drug whose efficacy remains high in the GMS, unlike, for example DHA/piperaquine \[20\]. The proposed study will help to assess the efficacy and feasibility of prophylaxis to prevent malaria in forest workers, help to identify the optimal regimen, and predict its efficacy in reducing overall transmission. The proposed study is a critical step for future use of chemoprophylaxis to protect forest workers in the GMS against malaria. Funder: Wellcome Trust of Great Britain grant number 106698/Z/14/Z and 220211.

Timeline

Start

2020-03-11

Primary completion

2021-03-17

Completion

2021-03-17

Outcome

Met primary endpoint

paper 123 (17%, 15-20) of 714 in the multivitamin group (absolute risk difference 15%, 95% CI 12-18; p<0·0001). PMID 36174595 ↗

Publications

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• Background West African Network for Clinical Trials of Antimalarial Drugs (WANECAM). Pyronaridine-artesunate or dihydroartemisinin-piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial. Lancet. 2018 Apr 7;391(10128):1378-1390. doi: 10.1016/S0140-6736(18)30291-5. Epub 2018 Mar 29.
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• Tripura R, von Seidlein L, Sovannaroth S, Peto TJ, Callery JJ, Sokha M, Ean M, Heng C, Conradis-Jansen F, Madmanee W, Peerawaranun P, Waithira N, Khonputsa P, Jongdeepaisal M, Pongsoipetch K, Chotthanawathit P, Soviet U, Pell C, Duanguppama J, Rekol H, Tarning J, Imwong M, Mukaka M, White NJ, Dondorp AM, Maude RJ. Antimalarial chemoprophylaxis for forest goers in southeast Asia: an open-label, individually randomised controlled trial. Lancet Infect Dis. 2023 Jan;23(1):81-90. doi: 10.1016/S1473-3099(22)00492-3. Epub 2022 Sep 26.
• Maude RJ, Tripura R, Ean M, Sokha M, Peto TJ, Callery JJ, Imwong M, Vongpromek R, Tarning J, Mukaka M, Waithira N, Soviet O, von Seidlein L, Sovannaroth S. Study protocol: an open-label individually randomised controlled trial to assess the efficacy of artemether-lumefantrine prophylaxis for malaria among forest goers in Cambodia. BMJ Open. 2021 Jul 7;11(7):e045900. doi: 10.1136/bmjopen-2020-045900.

Drugs

Indications