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RECRUITINGPhase 3INTERVENTIONAL

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are: * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) * is the tolerability and safety of TQRevised acceptable * is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.

Who May Be Eligible (Plain English)

Who May Qualify: - P. vivax peripheral parasitaemia (mono-infection) - G6PD normal status (G6PD activity ≥70% 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 - Written willing to sign a consent form - Living in the study area and willing to be followed for six months Who Should NOT Join This Trial: - Danger signs or symptoms of severe malaria - Anaemia (defined as Hb \<8g/dl) - Pregnant or lactating females - Regular use of drugs with haemolytic potential - Known hypersensitivity to any of the study drugs. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * P. vivax peripheral parasitaemia (mono-infection) * G6PD normal status (G6PD activity ≥70% 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 * 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 * Anaemia (defined as Hb \<8g/dl) * Pregnant or lactating females * Regular use of drugs with haemolytic potential * Known hypersensitivity to any of the study drugs.

Treatments Being Tested

DRUG

Tafenoquine

oral treatment

DRUG

Primaquine

oral treatment

Locations (4)

Dr Marcus Lacerda
Manaus, Brazil
Arba Minch General Hospital
Arba Minch, Ethiopia
Puskesmas Hanura
Hanura, Indonesia
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Papua New Guinea