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Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

RecruitingPhase 4Ages 18 Years - anyAllMenzies School of Health Research
NCT07468513 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * • 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 (SDBioline, ROK)) * Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours * Age ≥18 years * Haemoglobin at presentation ≥8g/dl * Written informed consent * Living in the study area and willing to be followed for six months. Exclusion Criteria: * • 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.
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What it tests

  • 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
  • Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).
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Where

4 sites
Dr Marcus Lacerda
Manaus, Brazil
Arba Minch General Hospital
Arba Minch, Ethiopia
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Papua New Guinea
Papua New Guinea Institute of Medical Research
Port Moresby, Papua New Guinea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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