Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

Recruiting now · Phase 4

Conditions studied: Vivax Malaria, G6PD Deficiency

In brief

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)

Key facts

Study ID

NCT07468513

Run by

Menzies School of Health Research

People needed

100

Starts

2024-05-17

Expected to finish

2028-12-31

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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.

Where it is running

• Dr Marcus Lacerda — Manaus, Brazil (enrolling)
• Dr Moses Laman and Dr Brioni Moore — Alexishafen, Madang Province, Papua New Guinea (enrolling)
• Papua New Guinea Institute of Medical Research — Port Moresby, Magang, Papua New Guinea (enrolling)
• Arba Minch General Hospital — Arba Minch, Ethiopia

Full record on ClinicalTrials.gov

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