Vivax MalariaPhase 3TADORENCT06148792
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
A Phase 3 study testing Tafenoquine and Primaquine in people with Vivax Malaria, run by Menzies School of Health Research at 4 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vivax Malaria
- What is being tested?
- Tafenoquine and Primaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,090 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 10 May 2024to 1 Mar 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Ethiopia1 site, 1 recruiting
- Recruiting
Arba Minch General Hospital
Arba Minch
Tamiru Shibiru Degaga, MD
Indonesia1 site, 1 recruiting
- Not yet recruiting
Puskesmas Hanura
Hanura
Inge Prof Sutanto, 000, sutanto.inge@yahoo.com
Erni Dr Juwita
Papua New Guinea1 site, 1 recruiting
- Recruiting
Dr Moses Laman and Dr Brioni Moore
Alexishafen
About this study
Official title: A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
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.
- Conditions
- Vivax Malaria
- Being tested
- Tafenoquine, Primaquine
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafenoquineDrug
oral treatment
PrimaquineDrug
oral treatment
| Study group | Role | What they receive |
|---|---|---|
| TQRevised | Experimental | Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg) Receives: Drug: Tafenoquine |
| TQStandard | Active comparator | Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard) Receives: Drug: Tafenoquine |
| PQ7 | Experimental | Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7) Receives: Drug: Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 42 days
Meth Hb concentration
day 7 methaemoglobin concentration
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start10 May 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vivax MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Arba Minch University, Addis Ababa University, Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia, Curtin University, Papua New Guinea Institute of Medical Research
- Responsible party
- Sponsor
- Investigators
- Kamala N Thriemer, PhD, Principal investigator, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148792
- Sponsor's protocol ID
- TADORE
- Acronym
- TADORE
- Status last verified
- Apr 2025
- First submitted
- 19 Nov 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes