Status:
RECRUITING
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
University of Melbourne
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Conditions:
Vivax Malaria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
1090 Patients enrolled
Trial Details
Trial ID
NCT06148792
Start Date
May 10 2024
End Date
March 1 2027
Last Update
July 18 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr Marcus Lacerda
Manaus, Brazil
2
Arba Minch General Hospital
Arba Minch, Ethiopia
3
Puskesmas Hanura
Hanura, Indonesia
4
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Papua New Guinea