A Phase 3 interventional study of Tafenoquine and Primaquine in Vivax Malaria, sponsored by Menzies School of Health Research. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Menzies School of Health Research · Phase 3, Interventional, and Treatment
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:
123 studies on the registry are indexed under Malaria, Vivax; 19 are open to participants now.
This study's planned enrollment of 1,090 is above the median of 150 across 103 interventional studies indexed under Malaria, Vivax.
Browse Malaria, Vivax studies →Menzies School of Health Research is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)
Drug: Tafenoquine
Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)
Drug: Tafenoquine
Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)
Drug: Primaquine
oral treatment
oral treatment
The incidence risk of vivax parasitaemia
The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy. * compared between TQRevised and the PQ7 (non-inferiority) * compared between TQRevised and TQStandard (superiority)
Time frame: 4 months
The incidence risk of vivax parasitaemia
The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7
Time frame: 4 months
The incidence risk of symptomatic vivax parasitaemia
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy
Time frame: 4 months
The incidence risk of vivax parasitaemia
The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy
Time frame: 6 months
The incidence risk of symptomatic vivax parasitaemia
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy
Time frame: 6 months
The incidence rate of vivax parasitaemia
The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy
Time frame: 6 months
The incidence rate of symptomatic vivax parasitaemia
The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy
Time frame: 6 months
The incidence risk of anaemia
The incidence risk of developing severe anaemia (Hb \< 5g/dl) or moderate (5g/dl and \<7g/dl) anaemia within 7 and 14 days of starting treatment and/or requiring blood transfusion within the 6 months follow up period
Time frame: 7 and 14 days, 6 months
The incidence risk of an acute drop in Hb
The incidence risk of an acute drop in Hb of \>25% to \<7g/dl within 7 and 14 days of starting treatment
Time frame: 7 and 14 days
Adverse events
The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment
Time frame: 42 days
Meth Hb concentration
day 7 methaemoglobin concentration
Time frame: day 7
Plan to share: Yes
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Studies of the drugs tested here: Tafenoquine · Primaquine
Menzies School of Health Research