Vivax MalariaPhase 4NCT07468513
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
A Phase 4 study testing Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days and Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose). in people with Vivax Malaria and G6PD Deficiency, run by Menzies School of Health Research at 4 sites in 3 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vivax Malaria, G6PD Deficiency
- What is being tested?
- Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days and Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 17 May 2024to 31 Dec 2028
- Phase
- Phase 4
- 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 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.
Who cannot join
- • 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Papua New Guinea2 sites, 2 recruiting
- Recruiting
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Madang Province
Dr Paula Tesine Doctor, Medical Doctor, +67570755875, paula.tesine@pngimr.org.pg
- Recruiting
Papua New Guinea Institute of Medical Research
Port Moresby, Magang
DR Moses Laman, +6754340208, moses.laman@pngimr.org.pg
Brazil1 site, 1 recruiting
- Recruiting
Dr Marcus Lacerda
Manaus
Aretha Omena, +55984208810, aretha.omena@gmail.com
Ethiopia1 site, 1 recruiting
- Not yet recruiting
Arba Minch General Hospital
Arba Minch
Tamiru Shibiru Degaga, MD, +251911704767, tamiru.shibiru@menzies.edu.au
About this study
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)
- Conditions
- Vivax Malaria, G6PD Deficiency
- Being tested
- Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days, Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).
- Keywords
- Primaquine in G6PD deficiency, Vivax malaria in G6PD deficient patients
- Medical subject headings
- Malaria, Vivax, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 daysDrug
Primaquine 1mg/kg/day for 7 days
Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).Drug
8 weekly Primaquine (0.75mg/kg dose).
| Study group | Role | What they receive |
|---|---|---|
| Participants with G6PD intermediate status receive another active regimen appropriate for intermedia | Active comparator | G6PD activity 30-<70% Receives: Drug: Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days |
| Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie | Active comparator | G6PD activity ≤30% Receives: Drug: Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of high dose primaquine
- 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.
- To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (<30% activity)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start17 May 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Curtin University, University of Melbourne, Arba Minch University, Papua New Guinea Institute of Medical Research, Mahidol Oxford Tropical Medicine Research Unit, Oxford University Clinical Research Unit, Vietnam, Universitas Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468513
- Sponsor's protocol ID
- HREC 24-4988
- Status last verified
- Nov 2025
- First submitted
- 27 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
- ClinicalTrials.gov ID
- NCT07468513
- Acronym / sponsor ID
- HREC 24-4988
- Conditions
- Vivax Malaria, G6PD Deficiency
- Keywords
- Primaquine in G6PD deficiency, Vivax malaria in G6PD deficient patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Curtin University, University of Melbourne, Arba Minch University, Papua New Guinea Institute of Medical Research, Mahidol Oxford Tropical Medicine Research Unit, Oxford University Clinical Research Unit, Vietnam, Universitas Indonesia
- Study start
- 17 May 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with G6PD intermediate status receive another active regimen appropriate for intermedia | Active comparator | Drug: Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 daysG6PD activity 30-<70% |
| Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie | Active comparator | Drug: Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).G6PD activity ≤30% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • P. vivax peripheral parasitaemia (mono-infection)
Key exclusion criteria (4 listed)
- • Danger signs or symptoms of severe malaria
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 |
|---|---|---|
| Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 daysPrimaquine 1mg/kg/day for 7 days | Drug | Participants with G6PD intermediate status receive another active regimen appropriate for intermedia |
| Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).8 weekly Primaquine (0.75mg/kg dose). | Drug | Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie |
Primary outcome
Safety and efficacy of high dose primaquine
Time frame: 6 Months
1. 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. 2. To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (<30% activity)
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 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Vivax Malaria
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Southeast Asia Dose Optimization of Tafenoquine
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An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
Malaria, Vivax
Not yet recruitingObservational study
Ethiopian Antimalarial Therapeutic Efficacy Study 2026
Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
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.
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Papua New Guinea
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days and Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose). in people with Vivax Malaria and G6PD Deficiency, run by Menzies School of Health Research at 4 sites in 3 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 7 inclusion and 4 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 12 Mar 2026. 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 Papua New Guinea, Brazil, Ethiopia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of high dose primaquine (time frame: 6 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 12 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.