Madang

Plasmodium vivax is the most widespread malaria species globally and a major cause of symptomatic malaria, especially affecting children aged 2 to 6 years. Papua New Guinea has intense transmission of P. vivax, making it an important location to study new treatments in children. The challenge with P. vivax is the dormant liver-stage parasites called hypnozoites, which can cause relapses and are resistant to most antimalarial drugs. This study aims to understand how the drug tafenoquine is processed in the bodies of Papua New Guinean children to help find better treatments for this infection. This open-label study involves healthy children aged 5 to 12 years with normal G6PD enzyme activity and no history of allergy to similar drugs. Participants are admitted to a health center for 2 to 4 days for monitoring and blood collection. They are randomly assigned to receive a single dose of tafenoquine (10 mg/kg) either with water and a low-fat meal or with chocolate-flavored milk containing fat and a low-fat meal. Blood samples are taken frequently over 56 days to study the drug's absorption and clearance, and safety tests are performed regularly. Children's health and safety are closely monitored throughout the study with blood tests, questionnaires about side effects, and clinical assessments. Researchers collect blood samples at multiple time points after dosing, including finger pricks and venous samples. They evaluate how the drug behaves in the body, its safety, and how well it is tolerated. The total study duration for each child is 56 days, with follow-up visits to ensure thorough observation of effects and safety.