Back to Search
Start Over
Study protocol: an open-label individually randomised controlled trial to assess the efficacy of artemether-lumefantrine prophylaxis for malaria among forest goers in Cambodia
- Source :
- BMJ Open, BMJ Open, Vol 11, Iss 7 (2021)
- Publication Year :
- 2021
- Publisher :
- BMJ, 2021.
-
Abstract
- IntroductionIn the Greater Mekong Subregion, 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 goers against malaria.Methods and analysisThe protocol describes an open-label randomised controlled trial of artemether-lumefantrine (AL) versus multivitamin as prophylaxis against malaria among forest goers aged 16–65 years in rural northeast Cambodia. The primary objective is to compare the efficacy of the artemisinin combination therapy AL versus a multivitamin preparation as defined by the 28-day PCR parasite positivity rate and incidence of confirmed clinical malaria of any species. The sample size is 2200 patient-episodes of duration 1 month in each arm. The duration of follow-up and prophylaxis for each participant is 1, 2 or 3 consecutive 28-day periods, followed by a further 28 days of post-exposure prophylaxis, depending on whether they continue to visit the forest. Analysis will be done both by intention to treat and per protocol.Ethics and disseminationAll participants will provide written, informed consent. Ethical approval was obtained from the Oxford Tropical Research Ethics Committee and the Cambodia National Ethics Committee for Health Research. Results will be disseminated by peer-reviewed open access publication together with open data.Trial registration numberNCT04041973; Pre-result.
- Subjects :
- Adult
medicine.medical_specialty
Artemether/lumefantrine
030231 tropical medicine
Forests
law.invention
Antimalarials
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Informed consent
law
parasitic diseases
medicine
Humans
030212 general & internal medicine
Malaria, Falciparum
Randomized Controlled Trials as Topic
Intention-to-treat analysis
business.industry
Public health
Artemether, Lumefantrine Drug Combination
public health
General Medicine
medicine.disease
Malaria
Open data
Treatment Outcome
Infectious Diseases
Family medicine
Chemoprophylaxis
tropical medicine
Medicine
epidemiology
Artemether
Cambodia
business
medicine.drug
Subjects
Details
- ISSN :
- 20446055
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....ad93e26bfd877bedd19a08e50c03833c
- Full Text :
- https://doi.org/10.1136/bmjopen-2020-045900