MalariaPhase 4VETNCT06575647
Vivax Elimination With Tafenoquine (VET) Study
A Phase 4 study testing Tafenoquine in people with Malaria and Malaria, Vivax, run by Shoklo Malaria Research Unit at 1 site in Thailand.
Trial summary
Theoretically, so long as there is a sink-source for malaria, transmission could be sustained at very low level (even at sub-microscopic oscillation) and reintroduce malaria either as sporadic cases or as resurgent outbreak. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria, Malaria, Vivax, Plasmodium Vivax
- What is being tested?
- Tafenoquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,242 participants
- Where
- 1 siteThailand
- Study dates
- 19 Feb 2025to 4 Oct 2025
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All village residence, aged >6 months who agrees to participate in the research.
Who cannot join
- People who refuse to participate
- People who are hypersensitive to Tafenoquine or Chloroquine
- Critically ill patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mass Drug Administration of Tafenoquine for P. Vivax Radical Cure: Safety and Feasibility Study
Theoretically, so long as there is a sink-source for malaria, transmission could be sustained at very low level (even at sub-microscopic oscillation) and reintroduce malaria either as sporadic cases or as resurgent outbreak. Uncertainty or shortage in financing has typically limited the malaria control or elimination projects to go further beyond the "Pre-elimination phase". Since malaria is no longer a top scoring mortality in national statistics in South East Asia, the governments/stakeholders are less willing to allocate from the austerity budget. There are proven evidence of resurgences after cessation of intervention programs where over 90% of all resurgence events were attributed to the interruption of malaria control programmes. In Karen state Myanmar-Thailand border, multiple factors including a cascade of political, financial, and logistical fiascos have compounded on the ongoing malaria elimination activities. Deleterious impacts after military coup since 2021 February including cessation of foreign investment, humanitarian aids, Civil Dis-obedience Movement of government staff and resuming armed-conflicts have strained the nearly failed health infrastructure of the country to a collapse stage. Interruption of the National Malaria Control activities due to the health system failure and accelerating combats countrywide could inevitably lead to the overturn in recently achieved malaria pre-elimination status especially in Karen state.
The disruption in health services within Myanmar is already resulting in an increase in malaria. Supply of the first line antimalarial drug artemether-lumefantrine, and other essential malaria control interventions, has been interrupted. The study is proposed to evaluate the impact of Mass Drug Administration (MDA) in 3 villages in Karen state with consistently high incidence of P. vivax and spatially clustered within 5 km radius. This proposal outlines a study to assess the feasibility and the safety of tafenoquine MDA.
Read the detailed description
Malaria remains a major health concern in Myanmar, particularly in Karen State along the Myanmar-Thailand border, where disruptions in health services have led to a significant increase in cases. To address this, a study is proposed to assess the feasibility and safety of Mass Drug Administration (MDA) using tafenoquine, a single-dose treatment for P. vivax malaria, which has been approved in several countries, including Thailand. The study will focus on three high-incidence villages in Karen State, Myanmar, with a total population of around 1,000.
In this study, the entire village population will be screened for malaria using Rapid Diagnostic Tests (RDT) and PCR, a highly sensitive method that detects parasites by copying and identifying their unique genetic material in blood samples. Participants who test positive for malaria by RDT will receive standard treatment. Additionally, all participants will be screened for their G6PD enzyme status and will receive tafenoquine if G6PD levels are above 6.0 units, or chloroquine prophylaxis if their enzyme levels are lower or if they are pregnant. Impact of MDA on reduction in malaria incidence by RDT and prevalence by PCR will also be evaluated as a secondary outcome of the study.
Participation is voluntary, and participants can withdraw at any time. They will receive full information about the study's risks and benefits before deciding whether to participate.
Risks:
According to previous research conducted both in this context and in other regions, tafenoquine and chloroquine are generally safe, with side effects usually being mild. The most common side effects are nausea and mild to moderate abdominal pain. A research team led by a medical doctor will be on hand to manage any side effects, and a referral system will be established in case of any serious adverse events.
Benefits:
If successful, the study could significantly reduce malaria cases in these villages. Additionally, it could provide valuable insights for implementing Tafenoquine MDA on a larger scale.
- Conditions
- Malaria, Malaria, Vivax, Plasmodium Vivax, Plasmodium Vivax Malaria
- Being tested
- Tafenoquine
- Keywords
- Mass drug administration, Plasmodium Vivax Malaria, Tafenoquine, Malaria elimination, Chloroquine prophylaxis
- Medical subject headings
- Malaria, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafenoquineDrug
Tafenoquine KODATEF® 100 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia).
Tafenoquine will be given as follows,
>10 kg to ≤ 20 kg - 150 mg (1 tab), >20 kg to ≤ 35 kg - 300 mg (2 tabs), > 35 kg - 450 mg (3 tabs)
| Study group | Role | What they receive |
|---|---|---|
| Tafenoquine | Experimental | Tafenoquine KODATEF® 100 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia).
Tafenoquine will be given as follows,
>10 kg to ≤ 20 kg - 150 mg (1 tab), >20 kg to ≤ 35 kg - 300 mg (2 tabs), > 35 kg - 450 mg (3 tabs) Receives: Drug: Tafenoquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events (SAEs) to assess safety and tolerability of Tafenoquine MDA
Number of (serious) adverse events reported
Measured: Baseline survey to end of Month-1 survey
Secondary outcomes (3)
To compare the incidence by Rapid Diagnostic Test (RDT) of P. vivax before and 1-3-6 months after providing the single round of MDA with Tafenoquine radical cure treatment
Malaria Incidence by RDT reported from malaria post at month 1, 3 and 6
Measured: Month 1, 3 and 6
To evaluate the adherence of healthcare workers to the SOP for implementing MDA of Tafenoquine.
Proportion of village health workers adhere to the SOP for G6PD testing \& documentation, tafenoquine administration and adverse event recording \& reporting.
Measured: Baseline survey and Month-1 survey
To compare the prevalence by PCR of P. vivax before and a month after providing the single round of MDA.
Difference in proportion positive to PCR positive before and a month after providing the single round of MDA.
Measured: Baseline survey and Month-1 survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start19 Feb 2025
- Primary completion4 Oct 2025
- Study completion4 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional study with safety and feasibility assessment
- Masking
- None (open label)
- Enrolment
- 1,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shoklo Malaria Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575647
- Sponsor's protocol ID
- MAL24004
- Acronym
- VET
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen JM, Smith DL, Cotter C, Ward A, Yamey G, Sabot OJ, Moonen B. Malaria resurgence: a systematic review and assessment of its causes. Malar J. 2012 Apr 24;11:122. doi: 10.1186/1475-2875-11-122.
PubMed 22531245Jaramillo-Ochoa R, Sippy R, Farrell DF, Cueva-Aponte C, Beltran-Ayala E, Gonzaga JL, Ordonez-Leon T, Quintana FA, Ryan SJ, Stewart-Ibarra AM. Effects of Political Instability in Venezuela on Malaria Resurgence at Ecuador-Peru Border, 2018. Emerg Infect Dis. 2019 Apr;25(4):834-836. doi: 10.3201/eid2504.181355. Epub 2019 Apr 17.
PubMed 30698522Nguyen TN, von Seidlein L, Nguyen TV, Truong PN, Hung SD, Pham HT, Nguyen TU, Le TD, Dao VH, Mukaka M, Day NP, White NJ, Dondorp AM, Thwaites GE, Hien TT. The persistence and oscillations of submicroscopic Plasmodium falciparum and Plasmodium vivax infections over time in Vietnam: an open cohort study. Lancet Infect Dis. 2018 May;18(5):565-572. doi: 10.1016/S1473-3099(18)30046-X. Epub 2018 Feb 2.
PubMed 29398388Okell LC, Bousema T, Griffin JT, Ouedraogo AL, Ghani AC, Drakeley CJ. Factors determining the occurrence of submicroscopic malaria infections and their relevance for control. Nat Commun. 2012;3:1237. doi: 10.1038/ncomms2241.
PubMed 23212366Poonkham, J. (2022). A Paradise Lost in the Indo-Pacific? Great Power Politics and International Relations of the Myanmar Tragedy. In: Yamahata, C., Anderson, B. (eds) Demystifying Myanmar's Transition and Political Crisis. Palgrave Macmillan, Singapore. https://doi.org/10.1007/978-981-16-6675-9_11
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Drug Administration of Tafenoquine for P. Vivax Radical Cure: Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT06575647
- Acronym / sponsor ID
- VET / MAL24004
- Conditions
- Malaria, Malaria, Vivax, Plasmodium Vivax, Plasmodium Vivax Malaria
- Keywords
- Mass drug administration, Plasmodium Vivax Malaria, Tafenoquine, Malaria elimination, Chloroquine prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,242 participants (actual)
- Lead sponsor
- Shoklo Malaria Research UnitUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 28 Aug 2024 (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.
Theoretically, so long as there is a sink-source for malaria, transmission could be sustained at very low level (even at sub-microscopic oscillation) and reintroduce malaria either as sporadic cases or as resurgent outbreak. Uncertainty or shortage in financing has typically limited the malaria control or elimination projects to go further beyond the "Pre-elimination phase". Since malaria is no longer a top scoring mortality in national statistics in South East Asia, the governments/stakeholders are less willing to allocate from the austerity budget. There are proven evidence of resurgences after cessation of intervention programs where over 90% of all resurgence events were attributed to the interruption of malaria control programmes. In Karen state Myanmar-Thailand border, multiple factors including a cascade of political, financial, and logistical fiascos have compounded on the ongoing malaria elimination activities. Deleterious impacts after military coup since 2021 February including cessation of foreign investment, humanitarian aids, Civil Dis-obedience Movement of government staff and resuming armed-conflicts have strained the nearly failed health infrastructure of the country to a collapse stage. Interruption of the National Malaria Control activities due to the health system failure and accelerating combats countrywide could inevitably lead to the overturn in recently achieved malaria pre-elimination status especially in Karen state.
The disruption in health services within Myanmar is already resulting in an increase in malaria. Supply of the first line antimalarial drug artemether-lumefantrine, and other essential malaria control interventions, has been interrupted. The study is proposed to evaluate the impact of Mass Drug Administration (MDA) in 3 villages in Karen state with consistently high incidence of P. vivax and spatially clustered within 5 km radius. This proposal outlines a study to assess the feasibility and the safety of tafenoquine MDA.
Detailed description
Malaria remains a major health concern in Myanmar, particularly in Karen State along the Myanmar-Thailand border, where disruptions in health services have led to a significant increase in cases. To address this, a study is proposed to assess the feasibility and safety of Mass Drug Administration (MDA) using tafenoquine, a single-dose treatment for P. vivax malaria, which has been approved in several countries, including Thailand. The study will focus on three high-incidence villages in Karen State, Myanmar, with a total population of around 1,000.
In this study, the entire village population will be screened for malaria using Rapid Diagnostic Tests (RDT) and PCR, a highly sensitive method that detects parasites by copying and identifying their unique genetic material in blood samples. Participants who test positive for malaria by RDT will receive standard treatment. Additionally, all participants will be screened for their G6PD enzyme status and will receive tafenoquine if G6PD levels are above 6.0 units, or chloroquine prophylaxis if their enzyme levels are lower or if they are pregnant. Impact of MDA on reduction in malaria incidence by RDT and prevalence by PCR will also be evaluated as a secondary outcome of the study.
Participation is voluntary, and participants can withdraw at any time. They will receive full information about the study's risks and benefits before deciding whether to participate.
Risks:
According to previous research conducted both in this context and in other regions, tafenoquine and chloroquine are generally safe, with side effects usually being mild. The most common side effects are nausea and mild to moderate abdominal pain. A research team led by a medical doctor will be on hand to manage any side effects, and a referral system will be established in case of any serious adverse events.
Benefits:
If successful, the study could significantly reduce malaria cases in these villages. Additionally, it could provide valuable insights for implementing Tafenoquine MDA on a larger scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional study with safety and feasibility assessment
| Arm | Type | Receives |
|---|---|---|
| Tafenoquine | Experimental | Drug: TafenoquineTafenoquine KODATEF® 100 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia). Tafenoquine will be given as follows, >10 kg to ≤ 20 kg - 150 mg (1 tab), >20 kg to ≤ 35 kg - 300 mg (2 tabs), > 35 kg - 450 mg (3 tabs) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All village residence, aged >6 months who agrees to participate in the research.
Key exclusion criteria (3 listed)
- People who refuse to participate
- People who are hypersensitive to Tafenoquine or Chloroquine
- Critically ill patient
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 |
|---|---|---|
| TafenoquineTafenoquine KODATEF® 100 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia). Tafenoquine will be given as follows, >10 kg to ≤ 20 kg - 150 mg (1 tab), >20 kg to ≤ 35 kg - 300 mg (2 tabs), > 35 kg - 450 mg (3 tabs) | Drug | Tafenoquine |
Primary outcome
Incidence of Serious Adverse Events (SAEs) to assess safety and tolerability of Tafenoquine MDA
Time frame: Baseline survey to end of Month-1 survey
Number of (serious) adverse events reported
3 secondary outcomes
To compare the incidence by Rapid Diagnostic Test (RDT) of P. vivax before and 1-3-6 months after providing the single round of MDA with Tafenoquine radical cure treatment
Time frame: Month 1, 3 and 6
To evaluate the adherence of healthcare workers to the SOP for implementing MDA of Tafenoquine.
Time frame: Baseline survey and Month-1 survey
To compare the prevalence by PCR of P. vivax before and a month after providing the single round of MDA.
Time frame: Baseline survey and Month-1 survey
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 6 Jan 2026.
- Results publication: PubMed 22531245Cohen JM, Smith DL, Cotter C, Ward A, Yamey G, Sabot OJ, Moonen B. Malaria resurgence: a systematic review and assessment of its causes. Malar J. 2012 Apr 24;11:122. doi: 10.1186/1475-2875-11-122.
- Results publication: PubMed 30698522Jaramillo-Ochoa R, Sippy R, Farrell DF, Cueva-Aponte C, Beltran-Ayala E, Gonzaga JL, Ordonez-Leon T, Quintana FA, Ryan SJ, Stewart-Ibarra AM. Effects of Political Instability in Venezuela on Malaria Resurgence at Ecuador-Peru Border, 2018. Emerg Infect Dis. 2019 Apr;25(4):834-836. doi: 10.3201/eid2504.181355. Epub 2019 Apr 17.
- Results publication: PubMed 29398388Nguyen TN, von Seidlein L, Nguyen TV, Truong PN, Hung SD, Pham HT, Nguyen TU, Le TD, Dao VH, Mukaka M, Day NP, White NJ, Dondorp AM, Thwaites GE, Hien TT. The persistence and oscillations of submicroscopic Plasmodium falciparum and Plasmodium vivax infections over time in Vietnam: an open cohort study. Lancet Infect Dis. 2018 May;18(5):565-572. doi: 10.1016/S1473-3099(18)30046-X. Epub 2018 Feb 2.
- Results publication: PubMed 23212366Okell LC, Bousema T, Griffin JT, Ouedraogo AL, Ghani AC, Drakeley CJ. Factors determining the occurrence of submicroscopic malaria infections and their relevance for control. Nat Commun. 2012;3:1237. doi: 10.1038/ncomms2241.
- Results publicationPoonkham, J. (2022). A Paradise Lost in the Indo-Pacific? Great Power Politics and International Relations of the Myanmar Tragedy. In: Yamahata, C., Anderson, B. (eds) Demystifying Myanmar's Transition and Political Crisis. Palgrave Macmillan, Singapore. https://doi.org/10.1007/978-981-16-6675-9_11
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tafenoquine in people with Malaria and Malaria, Vivax, run by Shoklo Malaria Research Unit at 1 site in Thailand.
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 1 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: finished, as of the sponsor's last update on 6 Jan 2026. 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 Thailand. 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?
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?
Incidence of Serious Adverse Events (SAEs) to assess safety and tolerability of Tafenoquine MDA (time frame: Baseline survey to end of Month-1 survey). 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 NCT06575647, which also lists 5 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 6 Jan 2026.