NCT04411836

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 960 (actual)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

Detailed description

* To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days). * To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen. * To assess the safety of tafenoquine compared to the high and low dose primaquine regimens. * To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Conditions

• Vivax Malaria
• Plasmodium Vivax
• Malaria, Vivax
• Malaria Relapse

Interventions

Type	Name	Description
DRUG	Tafenoquine	patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).
DRUG	Primaquine	patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Timeline

• Start date: 2021-04-25
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2020-06-02
• Last updated: 2024-10-08

Locations

6 sites across 4 countries: Cambodia, Ethiopia, Indonesia, Pakistan