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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
- ClinicalTrials.gov ID
- NCT06148792
- Acronym / sponsor ID
- TADORE / TADORE
- Conditions
- Vivax Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,090 participants (estimated)
- Lead sponsor
- Menzies School of Health ResearchUniversity, 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
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQRevised | Experimental | Drug: TafenoquinePatients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg) |
| TQStandard | Active comparator | Drug: TafenoquinePatients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard) |
| PQ7 | Experimental | Drug: PrimaquinePatients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafenoquineoral treatment | Drug | TQRevised, TQStandard |
| Primaquineoral treatment | Drug | PQ7 |
Primary outcome
The incidence risk of vivax parasitaemia
Time frame: 4 months
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)
10 secondary outcomes
The incidence risk of vivax parasitaemia
Time frame: 4 months
The incidence risk of symptomatic vivax parasitaemia
Time frame: 4 months
The incidence risk of vivax parasitaemia
Time frame: 6 months
The incidence risk of symptomatic vivax parasitaemia
Time frame: 6 months
The incidence rate of vivax parasitaemia
Time frame: 6 months
The incidence rate of symptomatic vivax parasitaemia
Time frame: 6 months
The incidence risk of anaemia
Time frame: 7 and 14 days, 6 months
The incidence risk of an acute drop in Hb
Time frame: 7 and 14 days
Adverse events
Time frame: 42 days
Meth Hb concentration
Time frame: day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes
Related trials for Vivax Malaria
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Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
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Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
Not yet recruitingPhase 1
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
Malaria Vaccine
Not yet recruitingPhase 2
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
Malaria, Malaria Vivax
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamala N Thriemer, PhD principal investigator
Menzies School of Health Research
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil, Ethiopia, Indonesia, Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hellen Mnjala (+610889468675, hellen.mnjala@menzies.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence risk of vivax parasitaemia (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.