NCT06148792

Brief Summary

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are:

  • is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days)
  • is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)
  • is the tolerability and safety of TQRevised acceptable
  • is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,090

participants targeted

Target at P75+ for phase_3

Timeline
10mo left

Started May 2024

Typical duration for phase_3

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2024Mar 2027

First Submitted

Initial submission to the registry

November 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 18, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

November 19, 2023

Last Update Submit

July 15, 2025

Conditions

Vivax Malaria

Outcome Measures

Primary Outcomes (1)

  • The incidence risk of vivax parasitaemia

    The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy. * compared between TQRevised and the PQ7 (non-inferiority) * compared between TQRevised and TQStandard (superiority)

    4 months

Secondary Outcomes (10)

  • The incidence risk of vivax parasitaemia

    4 months

  • The incidence risk of symptomatic vivax parasitaemia

    4 months

  • The incidence risk of vivax parasitaemia

    6 months

  • The incidence risk of symptomatic vivax parasitaemia

    6 months

  • The incidence rate of vivax parasitaemia

    6 months

  • +5 more secondary outcomes

Study Arms (3)

TQRevised

EXPERIMENTAL

Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)

Drug: Tafenoquine

TQStandard

ACTIVE COMPARATOR

Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)

Drug: Tafenoquine

PQ7

EXPERIMENTAL

Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)

Drug: Primaquine

Interventions

TafenoquineDRUG

oral treatment

TQRevisedTQStandard
PrimaquineDRUG

oral treatment

PQ7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • P. vivax peripheral parasitaemia (mono-infection)
  • G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
  • Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
  • Written informed consent
  • Living in the study area and willing to be followed for six months

You may not qualify if:

  • Danger signs or symptoms of severe malaria
  • Anaemia (defined as Hb \<8g/dl)
  • Pregnant or lactating females
  • Regular use of drugs with haemolytic potential
  • Known hypersensitivity to any of the study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr Marcus Lacerda

Manaus, Brazil

RECRUITING

Arba Minch General Hospital

Arba Minch, Ethiopia

RECRUITING

Puskesmas Hanura

Hanura, Indonesia

NOT YET RECRUITING

Dr Moses Laman and Dr Brioni Moore

Alexishafen, Papua New Guinea

RECRUITING

MeSH Terms

Conditions

Malaria, Vivax

Interventions

tafenoquinePrimaquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kamala N Thriemer, PhD

    Menzies School of Health Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hellen Mnjala

CONTACT

+610889468675hellen.mnjala@menzies.edu.au

kamala K Thriemer

CONTACT

+610889468644kamala.ley-thriemer@menzies.edu.au

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 28, 2023

Study Start

May 10, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations

ID(1)BR(1)PA(1)ET(1)