Last Updated: 29/10/2025

Mass Drug Administration of Tafenoquine for P. vivax Radical Cure: Safety and Feasibility Study (VET)

Objectives

This study aims to evaluate the impact of Mass Drug Administration (MDA) in 3 villages in Karen state, Myanmar-Thailand border, with consistently high incidence of P. vivax.

Primary objective: to assess the safety and tolerability of tafenoquine MDA.

Secondary objectives:

Compare the incidence of P. vivax before and 1-3-6 months after providing the single round of MDA with tafenoquine radical cure treatment.
Evaluate the adherence of healthcare workers to the SOP for implementing MDA of tafenoquine.
Compare the prevalence of P. vivax before and a month after providing the single round of MDA.

Principal Institution

Shoklo Malaria Research Unit (SMRU), Thailand

Principal Investigators / Focal Persons

Aung Pyae Phyo

Partner Institutions

Mahidol Oxford Tropical Medicine Research Unit (MORU), Thailand

Partner Investigators

Htet Htet Aung

Rationale and Abstract

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.

Study Design

ClinicalTrials.gov ID: NCT06575647

Study Type: Interventional

Study Phase: Phase 4

Study Design:

Allocation: N/A

Interventional Model: Single Group Assignment

Interventional Model Description: Cross-sectional study with safety and feasibility assessment

Masking: None (Open Label)

Primary Purpose: Treatment

External reference

Project Details Clinical Trials - Project details