MalariaPhase 4NCT02653898
Malaria Elimination Pilot Study in Military Forces in Cambodia
A Phase 4 study testing DHA-PIP, Primaquine and Artesunate + Mefloquine in people with Malaria and Parasitic Diseases, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Cambodia.
Trial summary
Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many have begun advocating for concerted malaria elimination efforts in Cambodia. However, there is currently no consensus on how malaria elimination is to be achieved with the tools available. Read more about this study
- Who is it for?
- Ages 2 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Parasitic Diseases
- What is being tested?
- DHA-PIP, Primaquine and Artesunate + Mefloquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteCambodia
- Study dates
- Jan 2016to Dec 2021
- Phase
- Phase 4
- 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 2 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Military volunteers aged 18-65 years of age plus their dependents > 2 years of age, eligible for care at an RCAF facility, or otherwise eligible Cambodian civilians at risk for contracting malaria who live within the designated geographical areas
- Able to give informed consent/assent
- Resides in the selected study areas, and available for monthly follow-up for 6 month study duration
- Agrees not to seek outside medical care for febrile illness unless referred by study team
- Authorized by local commander to participate in the study if on active duty
Who cannot join
- Allergic reaction or contraindication to dihydroartemisinin-piperaquine or primaquine or artesunate+mefloquine
- Pregnant or lactating female, or female of childbearing age, up to 50 years of age or otherwise individually assessed for childbearing potential, who does not agree to use an acceptable form of contraception during the study
- Judged by the investigator to be otherwise unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining Effective, Appropriate, Implementable Strategies for Malaria Elimination in Military Forces in Cambodia as a Model for Mobile Populations
Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many have begun advocating for concerted malaria elimination efforts in Cambodia. However, there is currently no consensus on how malaria elimination is to be achieved with the tools available.
In this study, the investigators will conduct operational research with the Royal Cambodian Armed Forces (RCAF) and National Malaria Center (CNM) to quantify the relative effectiveness of the two major interventional approaches - monthly malaria prophylaxis (MMP) or focused screening and treatment (FSAT) - in a head to-head comparison. In addition, the investigators will quantify the relative contribution of a recently advocated vector intervention for military personnel - the insecticide treated uniform (ITU) - in addition to other vector control measures currently employed by the RCAF. The investigators will employ the same permethrin insecticide self-application kits currently used by the US military. The investigators will estimate the cost effectiveness of each approach and attempt to define the best way forward for malaria elimination efforts in a critically important malaria reservoir in military population (and their dependents) who reside on the Thai-Cambodian border. The aim of the study is not only to conduct research to better define the best way forward in malaria elimination efforts in the high risk military populations, but to also build capacity within the RCAF to support and lead future elimination efforts in the most difficult-to-reach mobile populations.
Read the detailed description
This is a cluster-randomized, open label interventional study to determine the feasibility of achieving significant reduction in malaria cases in military encampments on the Thai-Cambodian border. The study will compare the effectiveness, safety, and tolerability of monthly malaria prophylaxis (MMP) to monthly focused screening and treatment (FSAT). This study will thus investigate the effectiveness of two potential interventions for malaria elimination. Subjects in the monthly malaria prophylaxis (MMP) arm will receive a standard 3-day treatment course of dihydroartemisinin-piperaquine on months 1, 2 and 3 and weekly low-dose primaquine (22.5mg for 12 weeks). Volunteers in the focused screening and treatment (FSAT) arm will be screened monthly and then treated for malaria following national treatment guidelines. For G6PD-deficient volunteers in the FSAT arm, primaquine will be administered weekly (45mg for 8 weeks) as radical curative and/or presumptive anti-relapse therapy. For G6PD normal volunteers with vivax infection, primaquine will be administered daily (15mg for 14 days). All FSAT volunteers with confirmed P. falciparum infection will receive a single, low dose (15mg) Primaquine as a P. falciparum transmission-blocking agent. The incremental benefit of an insecticide treated uniform (ITU) will also be assessed as a single-blind sham-controlled intervention in addition to personal protective measures currently employed by the RCAF. Volunteers will be followed monthly for a total of 6 months, to determine the proportion remaining malaria-free on day 180 following enrollment.
- Conditions
- Malaria, Parasitic Diseases
- Being tested
- DHA-PIP, Primaquine, Artesunate + Mefloquine, Permethrin (Insecticide treated uniform)
- Keywords
- Malaria, Antimalarials, Malaria Elimination, Mass Drug Administration, Malaria Prophylaxis, Mobile population, Drug resistance, Focused screening and treatment, Monthly Malaria Prophylaxis, Mass screening and treatment, Primaquine, Malaria transmission, Permethrin insecticide, Thai-Cambodian border, Cambodia, AFRIMS
- Medical subject headings
- Malaria, Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-PIPDrug
Also called DHA-piperaquine, Dihydroartemisinin-piperaquine
Administered monthly (weight-based) on days 1-3, during months 1, 2, and 3 in the MMP arm and also as a first line agent for P.v malaria recurrence in both MMP and FSAT treatment arms
PrimaquineDrug
22.5 mg weekly for 12 weeks in the MMP arm; low dose primaquine (15mg) for transmission blocking of P. falciparum or 14 days of primaquine (15mg) in G6PD normal volunteers or 8 weeks of low dose primaquine (45mg) in G6PD-deficient volunteers for radical cure of P. vivax
Artesunate + MefloquineDrug
Also called ASMQ, Artesunate-Mefloquine
Weight based; first line agent for P.f malaria infection diagnosed at monthly follow ups, administered on days 1-3 in subjects with malaria recurrence
Permethrin (Insecticide treated uniform)Drug
40% Permethrin IDA kit, applied once to the uniforms for volunteers assigned to ITU arm
| Study group | Role | What they receive |
|---|---|---|
| Focused Screening and Treatment + ITU | Active comparator | Approved antimalarial based on the malaria species identified on the monthly follow ups, following national treatment guidelines in Cambodia AND Insecticide Treated Uniform with 40% Permethrin; DHA-PIP or Artesunate + Mefloquine based on the malaria species, single dose Primaquine 15 mg in subjects with P.f uncomplicated malaria or Primaquine 45 mg weekly x 8 weeks in G6PD-deficient volunteers, or Primaquine 15 mg daily for 14 days in G6PD-normal volunteers. Receives: Drug: DHA-PIP; Drug: Primaquine; Drug: Artesunate + Mefloquine; Drug: Permethrin (Insecticide treated uniform) |
| Focused Screening and Treatment + sITU | Active comparator | Approved antimalarial based on the malaria species identified at the monthly follow up and following national treatment guidelines in Cambodia AND sham treated uniform. DHA-PIP or Artesunate + Mefloquine based on the malaria species, single dose Primaquine 15 mg in subjects with P.f uncomplicated malaria or Primaquine 45 mg weekly x 8 weeks in G6PD-deficient volunteers, or Primaquine 15 mg daily for 14 days in G6PD-normal volunteers. Receives: Drug: DHA-PIP; Drug: Primaquine; Drug: Artesunate + Mefloquine |
| Monthly Malaria Prophylaxis + ITU | Active comparator | Monthly DHA-PIP + weekly Primaquine 22.5 mg for 3 months; All subjects will also receive insecticide treated uniforms with 40% Permethrin Receives: Drug: DHA-PIP; Drug: Primaquine; Drug: Permethrin (Insecticide treated uniform) |
| Monthly Malaria Prophylaxis + sITU | Active comparator | Monthly DHA-PIP + weekly Primaquine 22.5 mg for 3 months; All subjects will also receive sham treated uniforms Receives: Drug: DHA-PIP; Drug: Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute risk reduction based on the proportion of subjects remaining malaria-free at the end of 6 months between the study arms as diagnosed by PCR-corrected malaria microscopy
Measured: 6 months
Secondary outcomes (12)
Overall rate of sexual stage infections at Months 1 through 6 in each arm based on a combined endpoint of light microscopy and PCR analysis for detection of gametocyte maturity.
Measured: 6 months
Number of participants with abnormal lab values and/or Adverse Events that are related to the treatments in each arm
Measured: 6 months
Kaplan-Meier survival analysis of asexual and sexual blood stage at 28-day intervals after treatment or prophylaxis up to 180 days
Measured: 6 months
Comparison of all-species and species-specific malaria incidence density in each arm over 180-day period
Measured: 6 months
Comparative incidence of malaria detected by RDT versus RT-PCR versus microscopy
Measured: 6 months
Comparative incidence of G6PD deficiency in the study population as determined by RDT, quantitative, and qualitative tests
Measured: At the time of enrollment
Estimate of apparent rates of preexisting immunity to malaria based on medical history, days of fever prior to presentation, and preexisting parasitological parameters (gametocytemia, low asexual stage parasitemias)
Measured: 6 months
Sensitivity and specificity assessment of the currently recommended rapid diagnostic test in Cambodia to detect moderate to severe G6PD deficiency using quantitative G6PD testing as the reference standard
Measured: At the time of enrollment
Odds ratio for P.v recurrence for each CYP2D6 phenotype
Measured: 6 months
Rate of cytochrome P450 2D6 genotypes/phenotypes in the population at risk
Measured: 6 months
Percent reduction in hemoglobin and HTC for each 2D6 haplotype in subjects with available CBC following PQ dosing
Measured: Day 3 (and day 7 in those volunteers with Hgb or HCT drop of at least 10% from baseline on Day 3)
Percentage of subjects with malaria recurrence for each CYP2D6 phenotype
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, Thailand
- Sponsor type
- Other government
- Collaborators
- National Center for Parasitology, Entomology, and Malaria Control (CNM), Ministry of National Defense, Royal Cambodian Armed Forces Department of Health
- Responsible party
- Sponsor
- Investigators
- Chanthap Lon, MD, Principal investigator, Armed Forces Research Institute of Medical Sciences, ThailandMariusz Wojnarski, MD, Study chair, Armed Forces Research Institute of Medical Sciences, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653898
- Sponsor's protocol ID
- WR2211
- Status last verified
- Mar 2021
- First submitted
- 8 Jan 2016
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The preliminary results, final report and key data will be shared with a broad array of stakeholders from Cambodia, the region, bilateral and multilateral implementing partners, and donor organizations.
Publications
Wojnarski M, Chaudhury S, Boonchan T, Bun R, Chann S, Gosi P, Soveasna K, Song S, Buathong N, Ittiverakul M, Sriwichai S, Arsanok M, Kuntawunginn W, Saingam P, Chaisatit C, Ponlawat A, Fansiri T, Vanachayangkul P, Jaichapor B, Sinoun M, Chuor CM, Kheangheng T, So M, Wanja E, Davidson S, Spring M, Rekol H, Dysoley L, Saly K, Livezey JR, Lin JT, Smith PL, Satharath P, Manning JE, Sok S, Saunders DL. Evaluating malaria elimination strategies among military forces in Cambodia: a multi-arm clinical trial comparing monthly prophylaxis and focused screening and treatment. BMC Infect Dis. 2025 Dec 12;26(1):84. doi: 10.1186/s12879-025-12207-4.
PubMed 41382293Manning J, Lon C, Spring M, Wojnarski M, Somethy S, Chann S, Gosi P, Soveasna K, Sriwichai S, Kuntawunginn W, Fukuda MM, Smith PL, Rekol H, Sinoun M, So M, Lin J, Satharath P, Saunders D. Cluster-randomized trial of monthly malaria prophylaxis versus focused screening and treatment: a study protocol to define malaria elimination strategies in Cambodia. Trials. 2018 Oct 16;19(1):558. doi: 10.1186/s13063-018-2931-x.
PubMed 30326952
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Effective, Appropriate, Implementable Strategies for Malaria Elimination in Military Forces in Cambodia as a Model for Mobile Populations
- ClinicalTrials.gov ID
- NCT02653898
- Acronym / sponsor ID
- WR2211
- Conditions
- Malaria, Parasitic Diseases
- Keywords
- Malaria, Antimalarials, Malaria Elimination, Mass Drug Administration, Malaria Prophylaxis, Mobile population, Drug resistance, Focused screening and treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, ThailandOther government
- Collaborators
- National Center for Parasitology, Entomology, and Malaria Control (CNM), Ministry of National Defense, Royal Cambodian Armed Forces Department of Health
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- 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.
Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many have begun advocating for concerted malaria elimination efforts in Cambodia. However, there is currently no consensus on how malaria elimination is to be achieved with the tools available.
In this study, the investigators will conduct operational research with the Royal Cambodian Armed Forces (RCAF) and National Malaria Center (CNM) to quantify the relative effectiveness of the two major interventional approaches - monthly malaria prophylaxis (MMP) or focused screening and treatment (FSAT) - in a head to-head comparison. In addition, the investigators will quantify the relative contribution of a recently advocated vector intervention for military personnel - the insecticide treated uniform (ITU) - in addition to other vector control measures currently employed by the RCAF. The investigators will employ the same permethrin insecticide self-application kits currently used by the US military. The investigators will estimate the cost effectiveness of each approach and attempt to define the best way forward for malaria elimination efforts in a critically important malaria reservoir in military population (and their dependents) who reside on the Thai-Cambodian border. The aim of the study is not only to conduct research to better define the best way forward in malaria elimination efforts in the high risk military populations, but to also build capacity within the RCAF to support and lead future elimination efforts in the most difficult-to-reach mobile populations.
Detailed description
This is a cluster-randomized, open label interventional study to determine the feasibility of achieving significant reduction in malaria cases in military encampments on the Thai-Cambodian border. The study will compare the effectiveness, safety, and tolerability of monthly malaria prophylaxis (MMP) to monthly focused screening and treatment (FSAT). This study will thus investigate the effectiveness of two potential interventions for malaria elimination. Subjects in the monthly malaria prophylaxis (MMP) arm will receive a standard 3-day treatment course of dihydroartemisinin-piperaquine on months 1, 2 and 3 and weekly low-dose primaquine (22.5mg for 12 weeks). Volunteers in the focused screening and treatment (FSAT) arm will be screened monthly and then treated for malaria following national treatment guidelines. For G6PD-deficient volunteers in the FSAT arm, primaquine will be administered weekly (45mg for 8 weeks) as radical curative and/or presumptive anti-relapse therapy. For G6PD normal volunteers with vivax infection, primaquine will be administered daily (15mg for 14 days). All FSAT volunteers with confirmed P. falciparum infection will receive a single, low dose (15mg) Primaquine as a P. falciparum transmission-blocking agent. The incremental benefit of an insecticide treated uniform (ITU) will also be assessed as a single-blind sham-controlled intervention in addition to personal protective measures currently employed by the RCAF. Volunteers will be followed monthly for a total of 6 months, to determine the proportion remaining malaria-free on day 180 following enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Focused Screening and Treatment + ITU | Active comparator | Drug: DHA-PIP, Drug: Primaquine, Drug: Artesunate + Mefloquine, Drug: Permethrin (Insecticide treated uniform)Approved antimalarial based on the malaria species identified on the monthly follow ups, following national treatment guidelines in Cambodia AND Insecticide Treated Uniform with 40% Permethrin; DHA-PIP or Artesunate + Mefloquine based on the malaria species, single dose Primaquine 15 mg in subjects with P.f uncomplicated malaria or Primaquine 45 mg weekly x 8 weeks in G6PD-deficient volunteers, or Primaquine 15 mg daily for 14 days in G6PD-normal volunteers. |
| Focused Screening and Treatment + sITU | Active comparator | Drug: DHA-PIP, Drug: Primaquine, Drug: Artesunate + MefloquineApproved antimalarial based on the malaria species identified at the monthly follow up and following national treatment guidelines in Cambodia AND sham treated uniform. DHA-PIP or Artesunate + Mefloquine based on the malaria species, single dose Primaquine 15 mg in subjects with P.f uncomplicated malaria or Primaquine 45 mg weekly x 8 weeks in G6PD-deficient volunteers, or Primaquine 15 mg daily for 14 days in G6PD-normal volunteers. |
| Monthly Malaria Prophylaxis + ITU | Active comparator | Drug: DHA-PIP, Drug: Primaquine, Drug: Permethrin (Insecticide treated uniform)Monthly DHA-PIP + weekly Primaquine 22.5 mg for 3 months; All subjects will also receive insecticide treated uniforms with 40% Permethrin |
| Monthly Malaria Prophylaxis + sITU | Active comparator | Drug: DHA-PIP, Drug: PrimaquineMonthly DHA-PIP + weekly Primaquine 22.5 mg for 3 months; All subjects will also receive sham treated uniforms |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Military volunteers aged 18-65 years of age plus their dependents > 2 years of age, eligible for care at an RCAF facility, or otherwise eligible Cambodian civilians at risk for contracting malaria who live within the designated geographical areas
- Able to give informed consent/assent
- Resides in the selected study areas, and available for monthly follow-up for 6 month study duration
- Agrees not to seek outside medical care for febrile illness unless referred by study team
- Authorized by local commander to participate in the study if on active duty
Key exclusion criteria (3 listed)
- Allergic reaction or contraindication to dihydroartemisinin-piperaquine or primaquine or artesunate+mefloquine
- Pregnant or lactating female, or female of childbearing age, up to 50 years of age or otherwise individually assessed for childbearing potential, who does not agree to use an acceptable form of contraception during the study
- Judged by the investigator to be otherwise unsuitable for study participation
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 |
|---|---|---|
| DHA-PIPAlso: DHA-piperaquine, Dihydroartemisinin-piperaquineAdministered monthly (weight-based) on days 1-3, during months 1, 2, and 3 in the MMP arm and also as a first line agent for P.v malaria recurrence in both MMP and FSAT treatment arms | Drug | Focused Screening and Treatment + ITU, Focused Screening and Treatment + sITU, Monthly Malaria Prophylaxis + ITU, Monthly Malaria Prophylaxis + sITU |
| Primaquine22.5 mg weekly for 12 weeks in the MMP arm; low dose primaquine (15mg) for transmission blocking of P. falciparum or 14 days of primaquine (15mg) in G6PD normal volunteers or 8 weeks of low dose primaquine (45mg) in G6PD-deficient volunteers for radical cure of P. vivax | Drug | Focused Screening and Treatment + ITU, Focused Screening and Treatment + sITU, Monthly Malaria Prophylaxis + ITU, Monthly Malaria Prophylaxis + sITU |
| Artesunate + MefloquineAlso: ASMQ, Artesunate-MefloquineWeight based; first line agent for P.f malaria infection diagnosed at monthly follow ups, administered on days 1-3 in subjects with malaria recurrence | Drug | Focused Screening and Treatment + ITU, Focused Screening and Treatment + sITU |
| Permethrin (Insecticide treated uniform)40% Permethrin IDA kit, applied once to the uniforms for volunteers assigned to ITU arm | Drug | Focused Screening and Treatment + ITU, Monthly Malaria Prophylaxis + ITU |
Primary outcome
The absolute risk reduction based on the proportion of subjects remaining malaria-free at the end of 6 months between the study arms as diagnosed by PCR-corrected malaria microscopy
Time frame: 6 months
12 secondary outcomes
Overall rate of sexual stage infections at Months 1 through 6 in each arm based on a combined endpoint of light microscopy and PCR analysis for detection of gametocyte maturity.
Time frame: 6 months
Number of participants with abnormal lab values and/or Adverse Events that are related to the treatments in each arm
Time frame: 6 months
Kaplan-Meier survival analysis of asexual and sexual blood stage at 28-day intervals after treatment or prophylaxis up to 180 days
Time frame: 6 months
Comparison of all-species and species-specific malaria incidence density in each arm over 180-day period
Time frame: 6 months
Comparative incidence of malaria detected by RDT versus RT-PCR versus microscopy
Time frame: 6 months
Comparative incidence of G6PD deficiency in the study population as determined by RDT, quantitative, and qualitative tests
Time frame: At the time of enrollment
Estimate of apparent rates of preexisting immunity to malaria based on medical history, days of fever prior to presentation, and preexisting parasitological parameters (gametocytemia, low asexual stage parasitemias)
Time frame: 6 months
Sensitivity and specificity assessment of the currently recommended rapid diagnostic test in Cambodia to detect moderate to severe G6PD deficiency using quantitative G6PD testing as the reference standard
Time frame: At the time of enrollment
Odds ratio for P.v recurrence for each CYP2D6 phenotype
Time frame: 6 months
Rate of cytochrome P450 2D6 genotypes/phenotypes in the population at risk
Time frame: 6 months
Percent reduction in hemoglobin and HTC for each 2D6 haplotype in subjects with available CBC following PQ dosing
Time frame: Day 3 (and day 7 in those volunteers with Hgb or HCT drop of at least 10% from baseline on Day 3)
Percentage of subjects with malaria recurrence for each CYP2D6 phenotype
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 41382293Wojnarski M, Chaudhury S, Boonchan T, Bun R, Chann S, Gosi P, Soveasna K, Song S, Buathong N, Ittiverakul M, Sriwichai S, Arsanok M, Kuntawunginn W, Saingam P, Chaisatit C, Ponlawat A, Fansiri T, Vanachayangkul P, Jaichapor B, Sinoun M, Chuor CM, Kheangheng T, So M, Wanja E, Davidson S, Spring M, Rekol H, Dysoley L, Saly K, Livezey JR, Lin JT, Smith PL, Satharath P, Manning JE, Sok S, Saunders DL. Evaluating malaria elimination strategies among military forces in Cambodia: a multi-arm clinical trial comparing monthly prophylaxis and focused screening and treatment. BMC Infect Dis. 2025 Dec 12;26(1):84. doi: 10.1186/s12879-025-12207-4.
- Derived from this study: PubMed 30326952Manning J, Lon C, Spring M, Wojnarski M, Somethy S, Chann S, Gosi P, Soveasna K, Sriwichai S, Kuntawunginn W, Fukuda MM, Smith PL, Rekol H, Sinoun M, So M, Lin J, Satharath P, Saunders D. Cluster-randomized trial of monthly malaria prophylaxis versus focused screening and treatment: a study protocol to define malaria elimination strategies in Cambodia. Trials. 2018 Oct 16;19(1):558. doi: 10.1186/s13063-018-2931-x.
- Individual participant dataSharing planned: Yes. The preliminary results, final report and key data will be shared with a broad array of stakeholders from Cambodia, the region, bilateral and multilateral implementing partners, and donor organizations.
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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.
Chanthap Lon, MD principal investigator
Armed Forces Research Institute of Medical Sciences, Thailand
Mariusz Wojnarski, MD study chair
Armed Forces Research Institute of Medical Sciences, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DHA-PIP, Primaquine and Artesunate + Mefloquine in people with Malaria and Parasitic Diseases, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The absolute risk reduction based on the proportion of subjects remaining malaria-free at the end of 6 months between the study arms as diagnosed by PCR-corrected malaria microscopy (time frame: 6 months). 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 NCT02653898, which also lists 2 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 2 Mar 2021.