Vivax Elimination With Tafenoquine (VET) Study

NCT06575647 | Completed Phase 4 DMC

• 1 other identifier: MAL24004
• Study Type: interventional
• Target: 1,242
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Malaria; Malaria, Vivax; Plasmodium Vivax; Plasmodium Vivax Malaria

Keywords

Mass drug administration; Plasmodium Vivax Malaria; Tafenoquine; Malaria elimination; Chloroquine prophylaxis

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events (SAEs) to assess safety and tolerability of Tafenoquine MDA

  Number of (serious) adverse events reported

  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

  Month 1, 3 and 6

• To evaluate the adherence of healthcare workers to the SOP for implementing MDA of Tafenoquine.

  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.

  Baseline survey and Month-1 survey

Study Arms (1)

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)

Drug: Tafenoquine

Interventions

Tafenoquine DRUG

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)

Tafenoquine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All village residence, aged \>6 months who agrees to participate in the research.

You may not qualify if:

• People who refuse to participate
• People who are hypersensitive to Tafenoquine or Chloroquine
• Critically ill patient

Sponsors & Collaborators

• Shoklo Malaria Research Unit: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (1)

Shoklo Malaria Research Unit (SMRU)

Mae Sot, Changwat Tak, Thailand

Location

Related Publications (5)

• 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.

  PMID: 22531245 RESULT

• Jaramillo-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.

  PMID: 30698522 RESULT

• Nguyen 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.

  PMID: 29398388 RESULT

• Okell 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.

  PMID: 23212366 RESULT

• Poonkham, 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

  RESULT

MeSH Terms

Conditions

Malaria; Malaria, Vivax

Interventions

tafenoquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional study with safety and feasibility assessment

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: February 19, 2025
• Primary Completion: October 4, 2025
• Study Completion: October 4, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

TH (1)