NCT07468513

Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\<30% activity)

Conditions

• Vivax Malaria
• G6PD Deficiency

Interventions

Type	Name	Description
DRUG	Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days	Primaquine 1mg/kg/day for 7 days
DRUG	Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).	8 weekly Primaquine (0.75mg/kg dose).

Timeline

• Start date: 2024-05-17
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

4 sites across 3 countries: Brazil, Ethiopia, Papua New Guinea