Rempi

Researchers are evaluating a revised weight-based dose of tafenoquine target dose 7.5mgkg 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.

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.