Rempi

Researchers are evaluating a revised weight-based dose of tafenoquine for treating vivax malaria. This Phase 3 trial aims to determine if the revised tafenoquine regimen, targeting 7.5 mg per kg of body weight, is not less effective than a high dose of primaquine (7 mg/kg over 7 days), and if it is better than a fixed 300 mg dose of tafenoquine. The study also looks at whether this revised dosing is safe, tolerable, and practical for patients. Participants will receive oral treatment with either the revised weight-based tafenoquine dose, fixed dose tafenoquine, or high dose primaquine. The study compares these groups to assess safety and effectiveness. Treatment dosing is adjusted based on weight bands to reach the target dose in the revised tafenoquine group. During the trial, researchers will monitor participants for four months to measure the risk of vivax parasitaemia returning. Participants will be followed for six months in total, with assessments including clinical monitoring and safety evaluations. The study focuses on ensuring the revised tafenoquine dose is both effective and well tolerated in patients with vivax malaria.

Researchers are evaluating the safety and effectiveness of high dose primaquine treatment in patients with Vivax Malaria who have different levels of G6PD enzyme activity. This Phase 4 observational study focuses on patients with intermediate G6PD activity (30-70%) and those with G6PD deficiency (less than 30%). The study aims to understand how well primaquine works and how safe it is for these groups. Patients with intermediate G6PD activity will receive schizontocidal treatment plus a high dose of primaquine at 1 mg/kg daily for 7 days. Those with G6PD deficiency will be treated with schizontocidal treatment plus weekly primaquine at a dose of 0.75 mg/kg for 8 weeks. Treatments are given according to the patient's enzyme activity level. Participants will be followed for six months to monitor safety and treatment effectiveness. Researchers will assess outcomes including safety measures and the ability of the treatment to control malaria. The study includes regular health checks, monitoring of hemoglobin levels, and tracking any side effects or complications over the study period.