Status:
COMPLETED
Study to Assess Efficacy of Artemether-lumefantrine Prophylaxis Against Forest Malaria in Cambodia (PAL_Cambodia)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Global Fund
Conditions:
Malaria
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief 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 malari...
Detailed Description
Summary of trial design An open-label randomised trial among forest goers comparing the ACT AL with a multivitamin with no antimalarial activity to evaluate the efficacy of prophylaxis, and to better...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2021
Estimated Enrollment :
1480 Patients enrolled
Trial Details
Trial ID
NCT04041973
Start Date
March 11 2020
End Date
March 17 2021
Last Update
March 20 2024
Active Locations (2)
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1
Pursat Referral Hospital/Kravanh Health Center
Pursat, Cambodia
2
Stung Treng Referral Hospital/Siem Pang Health Center
Stung Treng, Cambodia