Actively Recruiting
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
Led by Menzies School of Health Research · Updated on 2025-07-18
1090
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Menzies School of Health Research
Lead Sponsor
U
University of Melbourne
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a revised weight-based dose of tafenoquine (target dose 7.5mg/kg) to treat patients with vivax malaria. This Phase 3 trial aims to determine if this revised regimen is not worse than a high dose of primaquine given over seven days and if it is better than the standard fixed dose of tafenoquine. The study also looks at how well patients tolerate the revised dose and whether it is practical to use. Participants will be randomly assigned to one of three groups. One group will receive a single weight-based oral dose of tafenoquine along with schizontocidal treatment. Another group will receive a single fixed oral dose of 300mg tafenoquine plus schizontocidal treatment. The third group will receive schizontocidal treatment plus a high dose of primaquine given orally over seven days. The trial will monitor safety and effectiveness over several months. During the study, participants will be followed for six months. Researchers will assess the occurrence of vivax parasitaemia at 4 and 6 months as the main outcome. Other measurements include symptomatic vivax parasitaemia, anemia incidence at different time points, hemoglobin changes, adverse events, and methemoglobin levels. Participants must provide informed consent and live in the study area to allow regular follow-up and monitoring throughout the trial.
CONDITIONS
Brief Title
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- P. vivax peripheral parasitaemia (mono-infection)
- G6PD normal status (G6PD activity 670% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
- Fever (temperature 6537.5DAC) 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive schizontocidal treatment plus one of the study drug regimens: a single weight-based oral dose of tafenoquine, a single fixed oral dose of 300mg tafenoquine, or a high dose oral primaquine over 7 days.
1 baseline visit and daily dosing over 7 days
Duration - 6 months
Participants are followed to monitor for vivax parasitaemia, anaemia, adverse events, and other outcomes for up to 6 months after treatment.
Weekly visits for the first 6 weeks, then monthly visits up to 6 months
Trial Site Locations
Total: 4 locations
1
Dr Marcus Lacerda
Manaus, Brazil
Actively Recruiting
2
Arba Minch General Hospital
Arba Minch, Ethiopia
Actively Recruiting
3
Puskesmas Hanura
Hanura, Indonesia
Not Yet Recruiting
4
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Papua New Guinea
Actively Recruiting
Research Team
H
Hellen Mnjala
K
kamala K Thriemer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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