Revised tafenoquine dosing for treating vivax malaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a revised weight-based tafenoquine dosing regimen in patients with vivax malaria. Participants will receive a target dose of 7.5 mg/kg tafenoquine, which will be compared to a high dose of primaquine and a fixed dose of tafenoquine (300 mg). The study will assess whether the revised dosing is non-inferior to primaquine and superior to the fixed dose, while also evaluating the tolerability and safety of the new regimen. The trial will involve monitoring participants for six months to gather comprehensive data on outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Dr Marcus Lacerda
  Manaus, Brazil Recruiting
• Arba Minch General Hospital
  Arba Minch, Ethiopia Recruiting
• Dr Moses Laman and Dr Brioni Moore
  Alexishafen, Papua New Guinea Recruiting
• Puskesmas Hanura
  Hanura, Indonesia Not yet recruiting

Study contacts

• Principal investigator: Kamala N Thriemer, PhD — Menzies School of Health Research
• Study coordinator: Hellen Mnjala
• Email: hellen.mnjala@menzies.edu.au
• Phone: +610889468675

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-dose daily and weekly primaquine for vivax malaria in people with reduced G6PD activity

  This will test whether 1 mg/kg daily primaquine for 7 days is safe and works for adults with P. vivax and intermediate G6PD, and whether 0.75 mg/kg weekly primaquine is safe and works for adults with G6PD deficiency.

  Recruiting at 3 sites Phase 4 Menzies School of Health Research · Manaus and 3 other locations · NCT07468513

• Passive RSV antibody to protect Aboriginal and Torres Strait Islander infants

  This trial tests whether giving a single shot of the RSV antibody nirsevimab to Aboriginal and Torres Strait Islander infants around 6 months old can reduce RSV infections in the first year of life.

  Recruiting Phase 4 Menzies School of Health Research · Darwin, Northern Territory · NCT07578298

• Pneumococcal Vaccine Test for severely malnourished kids in hospital

  This study tests whether giving Pneumosil to children aged 6–59 months with severe acute malnutrition in hospital elicits a better immune response than a Typhoid vaccine, with follow-up visits over six months.

  Recruiting Phase 4 Menzies School of Health Research · Dili · NCT06817421

• Improving culturally safe healthcare for Aboriginal patients

  This study is trying to see if training healthcare workers in cultural safety and using more Aboriginal interpreters can improve the hospital experience and health outcomes for Aboriginal patients in Northern Territory.

  Recruiting Phase 2 Menzies School of Health Research · Darwin, Northern Territory and 3 other locations · NCT05629416

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.