A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Dr Marcus Lacerda
RECRUITING
Manaus
Ethiopia
Arba Minch General Hospital
RECRUITING
Arba Minch
Indonesia
Puskesmas Hanura
NOT_YET_RECRUITING
Hanura
Papua New Guinea
Dr Moses Laman and Dr Brioni Moore
RECRUITING
Alexishafen
Contact Information
Primary
Hellen Mnjala
hellen.mnjala@menzies.edu.au
+610889468675
Backup
kamala K Thriemer
kamala.ley-thriemer@menzies.edu.au
+610889468644
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 1090
Treatments
Experimental: TQRevised
Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)
Active_comparator: TQStandard
Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)
Experimental: PQ7
Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)
Related Therapeutic Areas
Sponsors
Collaborators: Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia, Curtin University, Arba Minch University, Addis Ababa University, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, University of Melbourne, Papua New Guinea Institute of Medical Research
Leads: Menzies School of Health Research

This content was sourced from clinicaltrials.gov