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Can a single dose of tafenoquine finally cure vivax malaria in southeast asia?

NCT ID NCT04704999

Cure Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests different doses of tafenoquine, a single-dose drug, to see if it can effectively cure Plasmodium vivax malaria by targeting dormant liver stages. The study involves 820 people in Southeast Asia with confirmed vivax malaria. Researchers aim to find a dose that prevents relapse better than current treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tafenoquine
What this could lead to
If successful, this could establish a single-dose cure for vivax malaria in Southeast Asia, replacing longer treatments and reducing relapse rates.
What could go wrong
The trial is testing dose optimization, and previous data showed the standard dose had low efficacy in this region. Higher doses may increase side effects like hemolysis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 820 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy * Fever or history of fever in the previous 7 days * Quantitative G6PD activity ≥70% of the population median * Weight \>10 kg and ≥2 years old * Ability to understand the study instructions and provide written informed consent. * Willing to be followed for 4 months Exclusion Criteria: * Pregnancy * Lactation * Hb \< 8 g/dL * Severe malaria * Blood transfusion in the last 4 months * History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine) * Any previous history of a haemolytic event Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study (e.g. chronic disease, medications that potentiate or inhibit CYP2D6 or CYP2C8 isoenzyme function)

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Conditions

The condition(s) this trial relates to.

Plasmodium vivax malaria Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plasmodium vivax malaria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lao Oxford Mahosot Hospital Wellcome Trust Research Unit (LOMWRU)

    RECRUITING

    Vientiane, Laos

  • Mahidol Oxford Tropical Medicine Research Unit (MORU), Cambodia

    RECRUITING

    Siem Reap, Cambodia

  • Mahidol Vivax Research Unit (MVRU)

    RECRUITING

    Bangkok, Thailand

  • Oxford University Clinical Research Unit (OUCRU)

    NOT_YET_RECRUITING

    Bình Phước, Vietnam

  • Oxford University Clinical Research Unit (OUCRU-Indonesia)

    NOT_YET_RECRUITING

    Jayapura, Indonesia

  • Shoklo Malaria Research Unit (SMRU)

    RECRUITING

    Bangkok, Thailand

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