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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oxford
• Collaborator: Global Fund
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Lumefantrine

Criteria

Inclusion criteria

• Male or female, adults aged between 16 and 65 years.

• Planning to travel to the forest within the next 72 hours and stay overnight.

• Written informed consent.

• Willingness and ability of the participants to comply with the study protocol for the duration of the study.

Exclusion criteria

• For females: known pregnancy or breast feeding

• Participants who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days.

• History of allergy or known contraindication to artemisinins, lumefantrine or multivitamins

• Documented or claimed history of cardiac conduction problems

• Severe vomiting or diarrhoea

• Signs/symptoms of clinical malaria (febrile or history of fever in the previous 24 hours) confirmed by RDT.