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Vivax Elimination With Tafenoquine (VET) Study

NCT06575647 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1242

Last updated 2026-01-06

No results posted yet for this study

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

Interventions

DRUG

Tafenoquine

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)

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Shoklo Malaria Research Unit

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2025-10-04
Completion
2025-10-04

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575647 on ClinicalTrials.gov