Actively Recruiting
Primaquine Treatment for Vivax Malaria in Patients with G6PD Intermediate and Deficient Status
Led by Menzies School of Health Research · Updated on 2026-03-12
100
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Menzies School of Health Research
Lead Sponsor
C
Curtin University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- P. vivax peripheral parasitaemia (mono-infection)
- G6PD intermediate or deficient status (G6PD activity 30-<70% or �30% of the adjusted male median as determined by the Standard G6PD test)
- Fever (temperature �37.5�B0C) or history of fever in the preceding 48 hours
- Age 18 years or older
- Haemoglobin at presentation 8 g/dl or higher
- Written informed consent
- Living in the study area and willing to be followed for six months.
You will not qualify if you...
- Danger signs or symptoms of severe malaria
- Pregnant or lactating females
- Regular use of drugs with haemolytic potential
- Known hypersensitivity to any of the study drugs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days for participants with G6PD intermediate status; 8 weeks for participants with G6PD deficient status
Participants receive schizontocidal treatment plus primaquine according to their G6PD enzyme activity level.
1 visit to start treatment and weekly visits for up to 8 weeks depending on regimen
Duration - 6 months
Participants are followed for safety and efficacy monitoring after treatment ends.
Periodic visits during the 6-month follow-up period
Trial Site Locations
Total: 4 locations
1
Dr Marcus Lacerda
Manaus, Brazil
Actively Recruiting
2
Arba Minch General Hospital
Arba Minch, Ethiopia
Not Yet Recruiting
3
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Madang Province, Papua New Guinea
Actively Recruiting
4
Papua New Guinea Institute of Medical Research
Port Moresby, Magang, Papua New Guinea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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