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Phase 4
Age: 18Years +
All Genders
ID07468513

Safety and Effectiveness of High Dose and Weekly Primaquine for Vivax Malaria in Adults with Intermediate or Deficient G6PD Levels

Led by Menzies School of Health Research · Updated on 2026-03-12

100

Participants Needed

4

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are observing the safety and effectiveness of high dose primaquine treatment in patients with Vivax Malaria who have different levels of G6PD enzyme activity. The study focuses on two groups those with intermediate G6PD activity 30-70% and those who are G6PD deficient less than 30%. The goal is to assess how well these dosing regimens work and their safety for these specific patient groups. Participants with G6PD activity between 30 and less than 70% will receive a treatment combining schizontocidal therapy and a high dose of primaquine at 1 mg per kg each day for 7 days. Those with G6PD activity below 30% will receive schizontocidal treatment plus primaquine once weekly at a dose of 0.75 mg per kg, repeated for 8 weeks. This is a non-randomized study without blinding. During the study, participants will be monitored for six months to evaluate treatment safety and effectiveness. Researchers will measure outcomes related to the safety and efficacy of the high-dose primaquine regimen over this period. Participants must provide informed consent and agree to follow-up visits, during which health status, including haemoglobin levels and fever history, will be assessed.

CONDITIONS

Brief Title

Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

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