MalariaPAL_CambodiaNCT04041973
Study to Assess Efficacy of Artemether-lumefantrine Prophylaxis Against Forest Malaria in Cambodia (PAL_Cambodia)
A study testing Artemether-lumefantrine and Multivitamin in people with Malaria, run by University of Oxford at 2 sites in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether-lumefantrine and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,480 participants
- Where
- 2 sitesCambodia
- Study dates
- 11 Mar 2020to 17 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Cambodia2 sites
Pursat Referral Hospital/Kravanh Health Center
Pursat
Stung Treng Referral Hospital/Siem Pang Health Center
Stung Treng
About this study
Official title: An Open-label Individually Randomised Controlled Trial to Assess the Efficacy of Artemether-lumefantrine Prophylaxis for Malaria Among Forest Goers in Cambodia
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.
Read the 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 understand high risk groups and locations of malaria transmission.
Artemether-lumefantrine prophylaxis trial
The study of AL versus a multivitamin will be a two-arm randomised open label comparative study. Laboratory assessments of malaria infection at baseline and days 28, 56, and 84 will be performed blind to treatment allocation and incidence of clinical cases during follow-up will be recorded.
Activities/outcomes
The main activity proposed is an in vivo clinical assessment of prophylaxis to prevent malaria in 4400 participant episodes in 50 villages in Stung Treng and Pursat Provinces, Cambodia. The subjects will be randomized in a one-to-one ratio between the ACT AL and a multivitamin preparation with no antimalarial activity.
The study sites have been chosen based on current information on incidence of malaria, known predominance of malaria among forest goers, presence of an established clinical research programme and feasibility to perform the proposed research activities.
Efficacy of AL ACT will be assessed through follow up visits every 28 days during a course of prophylaxis when temperature, symptom questionnaires, brief physical examinations, and malaria parasite PCR, lumefantrine levels, and, in selected individuals, parasite genetics will be performed. Episodes of confirmed clinical malaria among study participants at any time point between enrolment and follow-up will also be recorded.
All the organisations in this collaboration will work closely with local counterparts including the National Malaria Control Programmes (NMCPs), non-governmental and other relevant organisations. Training is an integral part of this collaborative working relationship, and the building of local research capacity is an essential component of all research plans.
All research-related activities, from study design, planning, implementation through to analysis and writing of reports will be performed jointly with local counterparts. Both on-the-job training and formal training will be provided when needed, in particular for Good Clinical Practice (GCP) skills.
The close interaction between WHO and its regional offices will ensure that new knowledge is disseminated efficiently and effectively throughout the region.
Study duration
The recruitment phase of the study is expected to last 12 months following the intended start of recruitment in July 2019. Training and community sensitization will precede study execution for 3 months. Data management and analysis, sample analysis (PCR, parasite genetics, lumefantrine levels), mathematical modelling and report writing are expected to take about 5 months. Therefore, the total time to complete the study will be about 20 months.
- Conditions
- Malaria
- Being tested
- Artemether-lumefantrine, Multivitamin
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
One tablet AL contains 20 mg artemether and 120 mg lumefantrine
The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest.
MultivitaminDietary supplement
One tablet contains Vitamin-A : 5000 USP units, Vitamin D: 400 USP Units, Ascorbic acid: 75 mg, Thiamine Mononitrate: 2 mg, Riboflavin: 3 mg, Niacin amide: 20 mg.
The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest.
| Study group | Role | What they receive |
|---|---|---|
| ACT arm | Experimental | Artemether-lumefantrine (AL) x 3 days followed by 1 day per week Receives: Drug: Artemether-lumefantrine |
| Multivitamin arm | Active comparator | Multivitamin x 3 days followed by 1 day per week Receives: Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of either clinical malaria with any Plasmodium species within 1-28, 29-56 or 57-84 days, or subclinical infection detected by PCR on days 28, 56 or 84.
Measured: 84 days
Secondary outcomes (10)
28-day, 56-day, and 84-day PCR Plasmodium positivity rate for each species
Measured: 28, 56 and, 84 days
Proportion of participants with confirmed malaria reported between day 0 and day 28 for each species
Measured: 28 days
Incidence of confirmed clinical malaria cases as reported to government health facilities and village malaria workers.surveillance data.
Measured: 1 year
Prevalence of Kelch13 mutations and other genetic markers of antimalarial drug resistance of known functional significance.
Measured: 28 days
Incidence of adverse events and serious adverse events by study arms during the course of prophylaxis.
Measured: 28 days
a. Number of people living in each village b. Number of people working in each reported location c. Number of people who have travelled to different locations within the preceding 2 months d. Number of people who have a mobile phone for their own use
Measured: 28 days
Latitude and longitude of the study participant over time in decimal degrees as recorded every 10-30 minutes by a GPS logging device.
Measured: 28 days
Overall prevalence of Plasmodium at baseline, stratified by season and risk factors.
Measured: Day 0
Day 0, 28, 56 and 84 capillary blood levels of lumefantrine.
Measured: 84 days
Prevalence of serological diagnostic markers of other infectious diseases.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start11 Mar 2020
- Primary completion17 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Global Fund
- Responsible party
- Sponsor
- Investigators
- Richard J Maude, M.D., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041973
- Sponsor's protocol ID
- MAL19001
- Acronym
- PAL_Cambodia
- Status last verified
- May 2022
- First submitted
- 23 Apr 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, individual participant data from this study will be available to researchers whose proposed purpose of use is approved by the data access committee at Mahidol Oxford Tropical Medicine Research Unit. Inquiries or requests for the data may be sent to datasharing@tropmedres.ac.
Publications
Guerra CA, Snow RW, Hay SI. A global assessment of closed forests, deforestation and malaria risk. Ann Trop Med Parasitol. 2006 Apr;100(3):189-204. doi: 10.1179/136485906X91512.
PubMed 16630376Thanh PV, Van Hong N, Van Van N, Van Malderen C, Obsomer V, Rosanas-Urgell A, Grietens KP, Xa NX, Bancone G, Chowwiwat N, Duong TT, D'Alessandro U, Speybroeck N, Erhart A. Epidemiology of forest malaria in Central Vietnam: the hidden parasite reservoir. Malar J. 2015 Feb 19;14:86. doi: 10.1186/s12936-015-0601-y.
PubMed 25880664Erhart A, Ngo DT, Phan VK, Ta TT, Van Overmeir C, Speybroeck N, Obsomer V, Le XH, Le KT, Coosemans M, D'alessandro U. Epidemiology of forest malaria in central Vietnam: a large scale cross-sectional survey. Malar J. 2005 Dec 8;4:58. doi: 10.1186/1475-2875-4-58.
PubMed 16336671Sanh NH, Van Dung N, Thanh NX, Trung TN, Van Co T, Cooper RD. Forest malaria in central Vietnam. Am J Trop Med Hyg. 2008 Nov;79(5):652-4.
PubMed 18981498Thang ND, Erhart A, Speybroeck N, Hung le X, Thuan le K, Hung CT, Ky PV, Coosemans M, D'Alessandro U. Malaria in central Vietnam: analysis of risk factors by multivariate analysis and classification tree models. Malar J. 2008 Jan 30;7:28. doi: 10.1186/1475-2875-7-28.
PubMed 18234102Erhart A, Thang ND, Hung NQ, Toi le V, Hung le X, Tuy TQ, Cong le D, Speybroeck N, Coosemans M, D'Alessandro U. Forest malaria in Vietnam: a challenge for control. Am J Trop Med Hyg. 2004 Feb;70(2):110-8.
PubMed 14993619Dysoley L, Kaneko A, Eto H, Mita T, Socheat D, Borkman A, Kobayakawa T. Changing patterns of forest malaria among the mobile adult male population in Chumkiri District, Cambodia. Acta Trop. 2008 Jun;106(3):207-12. doi: 10.1016/j.actatropica.2007.01.007. Epub 2008 Apr 7.
PubMed 18471797Moore SJ, Min X, Hill N, Jones C, Zaixing Z, Cameron MM. Border malaria in China: knowledge and use of personal protection by minority populations and implications for malaria control: a questionnaire-based survey. BMC Public Health. 2008 Oct 1;8:344. doi: 10.1186/1471-2458-8-344.
PubMed 18828901Gryseels C, Peeters Grietens K, Dierickx S, Xuan XN, Uk S, Bannister-Tyrrell M, Trienekens S, Ribera JM, Hausmann-Muela S, Gerrets R, D'Alessandro U, Sochantha T, Coosemans M, Erhart A. High Mobility and Low Use of Malaria Preventive Measures Among the Jarai Male Youth Along the Cambodia-Vietnam Border. Am J Trop Med Hyg. 2015 Oct;93(4):810-818. doi: 10.4269/ajtmh.15-0259. Epub 2015 Aug 17.
PubMed 26283747Grietens KP, Xuan XN, Ribera J, Duc TN, Bortel Wv, Ba NT, Van KP, Xuan HL, D'Alessandro U, Erhart A. Social determinants of long lasting insecticidal hammock use among the Ra-glai ethnic minority in Vietnam: implications for forest malaria control. PLoS One. 2012;7(1):e29991. doi: 10.1371/journal.pone.0029991. Epub 2012 Jan 12.
PubMed 22253852Lengeler C. Insecticide-treated bednets and curtains for preventing malaria. Cochrane Database Syst Rev. 2000;(2):CD000363. doi: 10.1002/14651858.CD000363.
PubMed 10796535Thang ND, Erhart A, Speybroeck N, Xa NX, Thanh NN, Ky PV, Hung le X, Thuan le K, Coosemans M, D'Alessandro U. Long-Lasting Insecticidal Hammocks for controlling forest malaria: a community-based trial in a rural area of central Vietnam. PLoS One. 2009 Oct 7;4(10):e7369. doi: 10.1371/journal.pone.0007369.
PubMed 19809502Son DH, Thuy-Nhien N, von Seidlein L, Le Phuc-Nhi T, Phu NT, Tuyen NTK, Tran NH, Van Dung N, Van Quan B, Day NPJ, Dondorp AM, White NJ, Thwaites GE, Hien TT. The prevalence, incidence and prevention of Plasmodium falciparum infections in forest rangers in Bu Gia Map National Park, Binh Phuoc province, Vietnam: a pilot study. Malar J. 2017 Nov 6;16(1):444. doi: 10.1186/s12936-017-2091-6.
PubMed 29110709York A. Seasonal malaria chemoprevention in the Sahel. Lancet Infect Dis. 2017 Jun;17(6):588. doi: 10.1016/S1473-3099(17)30255-4. No abstract available.
PubMed 28555586Snow RW. Seasonal Malaria Chemoprevention: An Evolving Research Paradigm. PLoS Med. 2016 Nov 22;13(11):e1002176. doi: 10.1371/journal.pmed.1002176. eCollection 2016 Nov.
PubMed 27875534
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Individually Randomised Controlled Trial to Assess the Efficacy of Artemether-lumefantrine Prophylaxis for Malaria Among Forest Goers in Cambodia
- ClinicalTrials.gov ID
- NCT04041973
- Acronym / sponsor ID
- PAL_Cambodia / MAL19001
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,480 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Global Fund
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 understand high risk groups and locations of malaria transmission.
Artemether-lumefantrine prophylaxis trial
The study of AL versus a multivitamin will be a two-arm randomised open label comparative study. Laboratory assessments of malaria infection at baseline and days 28, 56, and 84 will be performed blind to treatment allocation and incidence of clinical cases during follow-up will be recorded.
Activities/outcomes
The main activity proposed is an in vivo clinical assessment of prophylaxis to prevent malaria in 4400 participant episodes in 50 villages in Stung Treng and Pursat Provinces, Cambodia. The subjects will be randomized in a one-to-one ratio between the ACT AL and a multivitamin preparation with no antimalarial activity.
The study sites have been chosen based on current information on incidence of malaria, known predominance of malaria among forest goers, presence of an established clinical research programme and feasibility to perform the proposed research activities.
Efficacy of AL ACT will be assessed through follow up visits every 28 days during a course of prophylaxis when temperature, symptom questionnaires, brief physical examinations, and malaria parasite PCR, lumefantrine levels, and, in selected individuals, parasite genetics will be performed. Episodes of confirmed clinical malaria among study participants at any time point between enrolment and follow-up will also be recorded.
All the organisations in this collaboration will work closely with local counterparts including the National Malaria Control Programmes (NMCPs), non-governmental and other relevant organisations. Training is an integral part of this collaborative working relationship, and the building of local research capacity is an essential component of all research plans.
All research-related activities, from study design, planning, implementation through to analysis and writing of reports will be performed jointly with local counterparts. Both on-the-job training and formal training will be provided when needed, in particular for Good Clinical Practice (GCP) skills.
The close interaction between WHO and its regional offices will ensure that new knowledge is disseminated efficiently and effectively throughout the region.
Study duration
The recruitment phase of the study is expected to last 12 months following the intended start of recruitment in July 2019. Training and community sensitization will precede study execution for 3 months. Data management and analysis, sample analysis (PCR, parasite genetics, lumefantrine levels), mathematical modelling and report writing are expected to take about 5 months. Therefore, the total time to complete the study will be about 20 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT arm | Experimental | Drug: Artemether-lumefantrineArtemether-lumefantrine (AL) x 3 days followed by 1 day per week |
| Multivitamin arm | Active comparator | Dietary Supplement: MultivitaminMultivitamin x 3 days followed by 1 day per week |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrineOne tablet AL contains 20 mg artemether and 120 mg lumefantrine The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest. | Drug | ACT arm |
| MultivitaminOne tablet contains Vitamin-A : 5000 USP units, Vitamin D: 400 USP Units, Ascorbic acid: 75 mg, Thiamine Mononitrate: 2 mg, Riboflavin: 3 mg, Niacin amide: 20 mg. The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest. | Dietary supplement | Multivitamin arm |
Primary outcome
Composite endpoint of either clinical malaria with any Plasmodium species within 1-28, 29-56 or 57-84 days, or subclinical infection detected by PCR on days 28, 56 or 84.
Time frame: 84 days
10 secondary outcomes
28-day, 56-day, and 84-day PCR Plasmodium positivity rate for each species
Time frame: 28, 56 and, 84 days
Proportion of participants with confirmed malaria reported between day 0 and day 28 for each species
Time frame: 28 days
Incidence of confirmed clinical malaria cases as reported to government health facilities and village malaria workers.surveillance data.
Time frame: 1 year
Prevalence of Kelch13 mutations and other genetic markers of antimalarial drug resistance of known functional significance.
Time frame: 28 days
Incidence of adverse events and serious adverse events by study arms during the course of prophylaxis.
Time frame: 28 days
a. Number of people living in each village b. Number of people working in each reported location c. Number of people who have travelled to different locations within the preceding 2 months d. Number of people who have a mobile phone for their own use
Time frame: 28 days
Latitude and longitude of the study participant over time in decimal degrees as recorded every 10-30 minutes by a GPS logging device.
Time frame: 28 days
Overall prevalence of Plasmodium at baseline, stratified by season and risk factors.
Time frame: Day 0
Day 0, 28, 56 and 84 capillary blood levels of lumefantrine.
Time frame: 84 days
Prevalence of serological diagnostic markers of other infectious diseases.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 16630376Guerra CA, Snow RW, Hay SI. A global assessment of closed forests, deforestation and malaria risk. Ann Trop Med Parasitol. 2006 Apr;100(3):189-204. doi: 10.1179/136485906X91512.
- Background: PubMed 25880664Thanh PV, Van Hong N, Van Van N, Van Malderen C, Obsomer V, Rosanas-Urgell A, Grietens KP, Xa NX, Bancone G, Chowwiwat N, Duong TT, D'Alessandro U, Speybroeck N, Erhart A. Epidemiology of forest malaria in Central Vietnam: the hidden parasite reservoir. Malar J. 2015 Feb 19;14:86. doi: 10.1186/s12936-015-0601-y.
- Background: PubMed 16336671Erhart A, Ngo DT, Phan VK, Ta TT, Van Overmeir C, Speybroeck N, Obsomer V, Le XH, Le KT, Coosemans M, D'alessandro U. Epidemiology of forest malaria in central Vietnam: a large scale cross-sectional survey. Malar J. 2005 Dec 8;4:58. doi: 10.1186/1475-2875-4-58.
- Background: PubMed 18981498Sanh NH, Van Dung N, Thanh NX, Trung TN, Van Co T, Cooper RD. Forest malaria in central Vietnam. Am J Trop Med Hyg. 2008 Nov;79(5):652-4.
- Background: PubMed 18234102Thang ND, Erhart A, Speybroeck N, Hung le X, Thuan le K, Hung CT, Ky PV, Coosemans M, D'Alessandro U. Malaria in central Vietnam: analysis of risk factors by multivariate analysis and classification tree models. Malar J. 2008 Jan 30;7:28. doi: 10.1186/1475-2875-7-28.
- Background: PubMed 14993619Erhart A, Thang ND, Hung NQ, Toi le V, Hung le X, Tuy TQ, Cong le D, Speybroeck N, Coosemans M, D'Alessandro U. Forest malaria in Vietnam: a challenge for control. Am J Trop Med Hyg. 2004 Feb;70(2):110-8.
- Background: PubMed 18471797Dysoley L, Kaneko A, Eto H, Mita T, Socheat D, Borkman A, Kobayakawa T. Changing patterns of forest malaria among the mobile adult male population in Chumkiri District, Cambodia. Acta Trop. 2008 Jun;106(3):207-12. doi: 10.1016/j.actatropica.2007.01.007. Epub 2008 Apr 7.
- Background: PubMed 18828901Moore SJ, Min X, Hill N, Jones C, Zaixing Z, Cameron MM. Border malaria in China: knowledge and use of personal protection by minority populations and implications for malaria control: a questionnaire-based survey. BMC Public Health. 2008 Oct 1;8:344. doi: 10.1186/1471-2458-8-344.
- Background: PubMed 26283747Gryseels C, Peeters Grietens K, Dierickx S, Xuan XN, Uk S, Bannister-Tyrrell M, Trienekens S, Ribera JM, Hausmann-Muela S, Gerrets R, D'Alessandro U, Sochantha T, Coosemans M, Erhart A. High Mobility and Low Use of Malaria Preventive Measures Among the Jarai Male Youth Along the Cambodia-Vietnam Border. Am J Trop Med Hyg. 2015 Oct;93(4):810-818. doi: 10.4269/ajtmh.15-0259. Epub 2015 Aug 17.
- Background: PubMed 22253852Grietens KP, Xuan XN, Ribera J, Duc TN, Bortel Wv, Ba NT, Van KP, Xuan HL, D'Alessandro U, Erhart A. Social determinants of long lasting insecticidal hammock use among the Ra-glai ethnic minority in Vietnam: implications for forest malaria control. PLoS One. 2012;7(1):e29991. doi: 10.1371/journal.pone.0029991. Epub 2012 Jan 12.
- Background: PubMed 10796535Lengeler C. Insecticide-treated bednets and curtains for preventing malaria. Cochrane Database Syst Rev. 2000;(2):CD000363. doi: 10.1002/14651858.CD000363.
- Background: PubMed 19809502Thang ND, Erhart A, Speybroeck N, Xa NX, Thanh NN, Ky PV, Hung le X, Thuan le K, Coosemans M, D'Alessandro U. Long-Lasting Insecticidal Hammocks for controlling forest malaria: a community-based trial in a rural area of central Vietnam. PLoS One. 2009 Oct 7;4(10):e7369. doi: 10.1371/journal.pone.0007369.
- Individual participant dataSharing planned: Yes. De-identified, individual participant data from this study will be available to researchers whose proposed purpose of use is approved by the data access committee at Mahidol Oxford Tropical Medicine Research Unit. Inquiries or requests for the data may be sent to datasharing@tropmedres.ac.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Maude, M.D. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artemether-lumefantrine and Multivitamin in people with Malaria, run by University of Oxford at 2 sites in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of either clinical malaria with any Plasmodium species within 1-28, 29-56 or 57-84 days, or subclinical infection detected by PCR on days 28, 56 or 84. (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041973, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.