Vivax MalariaSCOPENCT05874271
Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
A study testing Revised case management package in people with Vivax Malaria and G6PD Deficiency, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 4 sites in Papua New Guinea.
Trial summary
Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax. P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that… Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Vivax Malaria, G6PD Deficiency
- What is being tested?
- Revised case management package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 794 participants
- Where
- 4 sitesPapua New Guinea
- Study dates
- 7 Aug 2023to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with vivax malaria
Who cannot join
- Patients who are pregnant
- Patients who are breastfeeding
- Patients with a Hb <8g/dL
- Patients with a previous adverse reaction to primaquine
- Patient with severe malaria
Trial locations and contacts
4 sites in 1 country.
Papua New Guinea4 sites
Napapar Health Centre
Kokopo, East New Britain Province
Mugil Health Centre
Madang, Madang Province
Baro Clinic
Vanimo, Sandaun Province
Wirui Clinic
Wewak, East Sepik Province
About this study
Official title: Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria
Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax.
- vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible only to 8 aminoquinolines such as primaquine. However, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (G6PD) deficiency. Additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence, hence ineffective primaquine treatment. Innovative solutions to the radical cure of both the blood and liver stages of P. vivax are urgently required.
Read more
The PNG National Department of Health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment regimens for patients with P. vivax malaria. This revised case management is to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance.
This will be a before-after longitudinal health facility-based study implemented at Napapar and Mugil health centres and Baro and Wirui clinics. A staged approach for the implementation of the revised case management strategy will be used, including patient education and counselling, community-based clinical review, with mixed methods evaluation.
- Conditions
- Vivax Malaria, G6PD Deficiency
- Being tested
- Revised case management package
- Keywords
- primaquine
- 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.
Revised case management packageCombination product
- Point-of-care quantitative G6PD testing using G6PD STANDARD (SD Biosensor) prior to use of primaquine (Day 0)
- Prescription of short course primaquine (7 mg/kg total) (Day 0):
- PQ7 (1 mg/kg/day for 7 days) if G6PD activity greater than 70 percent
- PQ14 (0.5 mg/kg/day for 14 days) if G6PD activity is 30-70 percent
- PQ8w (0.75 mg/kg/week for 8 weeks) if G6DP activity less than 30 percent
- Participant counselling at the health facility (Day 0):
- Supervision of first dose of primaquine
- Education regarding importance and risks of primaquine therapy and necessity to take primaquine with food
- Community based clinical review on Day 3 (and Day 7 for the first 300 participants) to detect and manage gastrointestinal or haemolytic adverse effects of treatment and encourage adherence to full treatment regime
- Improved malariometric surveillance and pharmacovigilance to support wider scale use of the revised case management
| Study group | Role | What they receive |
|---|---|---|
| Revised case management package | Experimental | Not described Receives: Combination Product: Revised case management package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment.
SAEs are collected during clinical review using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
Proportion of patients experiencing at least one Adverse Event of Special Interest (AESI) during treatment.
AESIs (haemolysis, methaemoglobinaemia and gastrointestinal discomfort) are collected during clinical review using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
Proportion of patients with P. vivax malaria who correctly receive all components of the revised case management package
Measured by completion of G6PD testing and the correct prescription of primaquine based on G6PD activity, completion of patients counselling and community based follow up on Day 3
Measured: 3 days
Secondary outcomes (35)
The proportion of patients with any AESI during treatment
AESIs are collected during clinical review using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
The proportion of patients with a gastrointestinal (GI) AESI during treatment
AESIs are collected during clinical review using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
The proportion of patients with an AESI related to haemolysis during treatment
AESIs are collected during clinical review using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
The proportion of patients an AESI related to methaemoglobinaemia
AESIs are collected during clinical review using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
Proportion of patients permanently stopping PQ before end of treatment
Discontinuation of PQ will be assessed using a study-specific questionnaire
Measured: During treatment (up to 8 weeks)
The proportion of patients receiving correct treatment based on G6PD activity
This will be assessed by linking patients G6PD activity results measured during study enrolment with primaquine dose prescribed on the same day
Measured: 1 day
Proportion of patients who were reviewed on Day 3 and Day 7
This will be assessed by linking patients enrolment data with Day 3 and Day 7 clinical review data
Measured: 1 week
Perception of and experience with new radical cure tools among health care providers and community members
This will be assessed using stakeholder interviews
Measured: 6 months
Proportion of health care practitioners who comply with the revised radical cure treatment algorithm
The outcome will be assessed from patients' enrolment data
Measured: 1 day
Proportion of patients receiving a SD Biosensor G6PD test
The outcome will be assessed from patients' enrolment data
Measured: 1 day
Proportion of eligible P. vivax malaria patients receiving the correct dose of primaquine based on the result of the G6PD test
The outcome will be assessed from patients' enrolment data
Measured: 1 day
Proportion of P. vivax malaria patients who are ineligible for daily primaquine and are incorrectly given primaquine (including infants, pregnant females and G6PD deficient patients)
The outcome will be assessed from patients' enrolment data
Measured: 1 day
Proportion of P. vivax malaria patients that are reviewed on Day 3
This will be assessed by linking patients' enrolment data with clinical review data
Measured: 3 days
Proportion of P. vivax malaria patients that adhere to their prescribed primaquine regimen
This will be assessed by linking patients' enrolment data with clinical review data
Measured: 3 days
Factors influencing acceptability and feasibility of the new radical cure tools among health care providers are identified
This will be assessed using stakeholder interviews, observations and focus groups
Measured: 3 days
Barriers and enablers of uptake and implementation at the sub-national levels are identified
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
Factors influencing compliance with G6PD testing and perceptions of new drug regimens and serious adverse events among health care providers are identified
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
Required knowledge, skills, and training to administer the revised case management and patient-counselling identified
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
Factors influencing the barriers and facilitators to patient adherence to primaquine after the rollout of the revised case management identified
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
Factors influencing the acceptability and feasibility of community-based clinical review at Day 3 of primaquine treatment identified.
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
Perceptions of the new radical cure tools and serious adverse events at the community level identified
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
Local acceptability of the revised case management algorithms among patients, their families, and healthcare workers established
This will be assessed using stakeholder interviews and focus groups
Measured: 18 months
The monthly incidence of confirmed symptomatic P. vivax malaria episodes (mono-infection or mixed) before implementation versus after implementation
This will be assessed by comparing facility surveillance data before implementation with facility surveillance data after implementation
Measured: 18 months
The prevalence of P. vivax parasitaemia in patients presenting with fever before implementation versus after implementation
This will be assessed by comparing cross-sectional data on n=200 patients (per facility) collected before implementation to the prevalence collected in n=200 patients (per facility) after implementation
Measured: 18 months
Cumulative risk of representation to the same clinic with symptomatic P. vivax malaria within 6 months
This will be assessed by linking patients' enrolment data
Measured: 18 months
Costs of implementing policy from a healthcare provider perspective, including health systems strengthening processes
This will be assessed from health system data collected throughout the study
Measured: 18 months
Household costs per P. vivax episode
This will be assessed from a household cost survey on a subset of patients
Measured: 3 days
Overall cost-effectiveness of changing policy if revised case management is effective
This will be assessed from health system data collected throughout the study
Measured: 18 months
Cost per episode of P. vivax malaria from the healthcare provider and societal perspectives
This will be assessed from health system data collected throughout the study
Measured: 18 months
Cost per component of the revised case management package
This will be assessed from health system data collected throughout the study
Measured: 18 months
If revised case management package is effective (significantly reduces the incidence of malaria), then the cost-effectiveness of implementing the revised case management as compared with usual care
This will be assessed from health system data collected throughout the study
Measured: 18 months
Proportion of CHWs who correctly act on early signs of haemolytic anaemia and GI events (i.e. refer patients for further medical review, instruct patient to discontinue treatment)
This will be assessed from clinical review data and study-specific questionnaire
Measured: 3 days
Number of patients with an SAE who are identified by community or clinic staff follow-up and referred to hospital for further management
This will be assessed by linking clinical review data, study specific questionnaire and SAE form
Measured: During treatment (up to 8 weeks)
The proportion of patients eligible to receive PQ who had a SAE during treatment
This will be assessed by linking enrolment data, clinical review, study specific questionnaire and SAE form
Measured: During treatment (up to 8 weeks)
Prevalence of severe anaemia in patients presenting with fever before and after implementation
This will be assessed by comparing the facility surveillance data before implementation with facility surveillance data after implementation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start7 Aug 2023
- Primary completion25 Oct 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 794 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, National Department of Health, Papua New Guinea, Menzies School of Health Research, University of Melbourne, Medicines for Malaria Venture, PATH, UNITAID
- Responsible party
- Sponsor
- Investigators
- Moses Laman, Dr, Principal investigator, Papua New Guinea Institute of Medical ResearchLeanne Robinson, Prof, Principal investigator, Macfarlane Burnet Institute for Medical Research and Public HealthLeo Makita, Principal investigator, National Department of Health, Papua New GuineaWilliam Pomat, Prof, Principal investigator, Papua New Guinea Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874271
- Sponsor's protocol ID
- MMV_PQ_21_02
- Other IDs
- U1111-1285-4864
- Acronym
- SCOPE
- Status last verified
- Aug 2026
- First submitted
- 5 May 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan will be made available to others. The results will be published in peer-reviewed open access journals and disseminated to stakeholders. De-identified quantitative data for the purposes of confirming risk of adverse events will be available to researchers who provide a methodological sound proposal that is in line with the aims of the approved protocol.
Publications
Fransisca L, Ome-Kaius M, Laman M, Poespoprodjo JR, Pasaribu AP, Sutanto I, Malai M, Nelwan E, Adella J, Abegini C, Ainur F, Amdara Y, Angeline S, Brown K, Burdam FH, Curry E, Daimen M, Daly P, Do T, Dori A, Douglas NM, Huegel H, Hutagalung AP, Jambert E, Jimanto V, Karo V, Kenangalem E, Kelebi T, Kisomb J, Laksono I, Lee G, Ley B, Mannion K, Plinduo J, Pukai I, Putri A, Rajasekhar M, Ronkentou S, Rosens E, Sakalidis VS, Satyagraha A, Simpson JA, Theodora M, Ubra R, Vakore N, Wansom T, Duparc S, Robinson LJ, Price RN. High-dose, short-course primaquine after point-of-care G6PD testing for the radical cure of Plasmodium vivax malaria: a safety study in Papua New Guinea and Indonesia. Lancet Reg Health West Pac. 2026 Jun 11;71:101903. doi: 10.1016/j.lanwpc.2026.101903. eCollection 2026 Jun.
PubMed 42326839SCOPE Study Group. High daily dose Short COurse PrimaquinE after G6PD testing for the radical cure of Plasmodium vivax malaria in Indonesia and Papua New Guinea: the SCOPE implementation study protocol. BMC Infect Dis. 2025 Jul 16;25(1):922. doi: 10.1186/s12879-025-11109-9.
PubMed 40670924
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria
- ClinicalTrials.gov ID
- NCT05874271
- Acronym / sponsor ID
- SCOPE / MMV_PQ_21_02
- Conditions
- Vivax Malaria, G6PD Deficiency
- Keywords
- primaquine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, National Department of Health, Papua New Guinea, Menzies School of Health Research, University of Melbourne, Medicines for Malaria Venture, PATH, UNITAID
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 24 May 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.
Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax.
- vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible only to 8 aminoquinolines such as primaquine. However, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (G6PD) deficiency. Additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence, hence ineffective primaquine treatment. Innovative solutions to the radical cure of both the blood and liver stages of P. vivax are urgently required.
The PNG National Department of Health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment regimens for patients with P. vivax malaria. This revised case management is to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance.
This will be a before-after longitudinal health facility-based study implemented at Napapar and Mugil health centres and Baro and Wirui clinics. A staged approach for the implementation of the revised case management strategy will be used, including patient education and counselling, community-based clinical review, with mixed methods evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revised case management package | Experimental | Combination Product: Revised case management package |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with vivax malaria
Key exclusion criteria (5 listed)
- Patients who are pregnant
- Patients who are breastfeeding
- Patients with a Hb <8g/dL
- Patients with a previous adverse reaction to primaquine
- Patient with 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 |
|---|---|---|
| Revised case management package1. Point-of-care quantitative G6PD testing using G6PD STANDARD (SD Biosensor) prior to use of primaquine (Day 0) 2. Prescription of short course primaquine (7 mg/kg total) (Day 0): * PQ7 (1 mg/kg/day for 7 days) if G6PD activity greater than 70 percent * PQ14 (0.5 mg/kg/day for 14 days) if G6PD activity is 30-70 percent * PQ8w (0.75 mg/kg/week for 8 weeks) if G6DP activity less than 30 percent 3. Participant counselling at the health facility (Day 0): * Supervision of first dose of primaquine * Education regarding importance and risks of primaquine therapy and necessity to take primaquine with food 4. Community based clinical review on Day 3 (and Day 7 for the first 300 participants) to detect and manage gastrointestinal or haemolytic adverse effects of treatment and encourage adherence to full treatment regime 5. Improved malariometric surveillance and pharmacovigilance to support wider scale use of the revised case management | Combination product | Revised case management package |
Primary outcome
Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment.
Time frame: During treatment (up to 8 weeks)
SAEs are collected during clinical review using a study-specific questionnaire
Proportion of patients experiencing at least one Adverse Event of Special Interest (AESI) during treatment.
Time frame: During treatment (up to 8 weeks)
AESIs (haemolysis, methaemoglobinaemia and gastrointestinal discomfort) are collected during clinical review using a study-specific questionnaire
Proportion of patients with P. vivax malaria who correctly receive all components of the revised case management package
Time frame: 3 days
Measured by completion of G6PD testing and the correct prescription of primaquine based on G6PD activity, completion of patients counselling and community based follow up on Day 3
35 secondary outcomes
The proportion of patients with any AESI during treatment
Time frame: During treatment (up to 8 weeks)
The proportion of patients with a gastrointestinal (GI) AESI during treatment
Time frame: During treatment (up to 8 weeks)
The proportion of patients with an AESI related to haemolysis during treatment
Time frame: During treatment (up to 8 weeks)
The proportion of patients an AESI related to methaemoglobinaemia
Time frame: During treatment (up to 8 weeks)
Proportion of patients permanently stopping PQ before end of treatment
Time frame: During treatment (up to 8 weeks)
The proportion of patients receiving correct treatment based on G6PD activity
Time frame: 1 day
Proportion of patients who were reviewed on Day 3 and Day 7
Time frame: 1 week
Perception of and experience with new radical cure tools among health care providers and community members
Time frame: 6 months
Proportion of health care practitioners who comply with the revised radical cure treatment algorithm
Time frame: 1 day
Proportion of patients receiving a SD Biosensor G6PD test
Time frame: 1 day
Proportion of eligible P. vivax malaria patients receiving the correct dose of primaquine based on the result of the G6PD test
Time frame: 1 day
Proportion of P. vivax malaria patients who are ineligible for daily primaquine and are incorrectly given primaquine (including infants, pregnant females and G6PD deficient patients)
Time frame: 1 day
Proportion of P. vivax malaria patients that are reviewed on Day 3
Time frame: 3 days
Proportion of P. vivax malaria patients that adhere to their prescribed primaquine regimen
Time frame: 3 days
Factors influencing acceptability and feasibility of the new radical cure tools among health care providers are identified
Time frame: 3 days
Barriers and enablers of uptake and implementation at the sub-national levels are identified
Time frame: 18 months
Factors influencing compliance with G6PD testing and perceptions of new drug regimens and serious adverse events among health care providers are identified
Time frame: 18 months
Required knowledge, skills, and training to administer the revised case management and patient-counselling identified
Time frame: 18 months
Factors influencing the barriers and facilitators to patient adherence to primaquine after the rollout of the revised case management identified
Time frame: 18 months
Factors influencing the acceptability and feasibility of community-based clinical review at Day 3 of primaquine treatment identified.
Time frame: 18 months
Perceptions of the new radical cure tools and serious adverse events at the community level identified
Time frame: 18 months
Local acceptability of the revised case management algorithms among patients, their families, and healthcare workers established
Time frame: 18 months
The monthly incidence of confirmed symptomatic P. vivax malaria episodes (mono-infection or mixed) before implementation versus after implementation
Time frame: 18 months
The prevalence of P. vivax parasitaemia in patients presenting with fever before implementation versus after implementation
Time frame: 18 months
Cumulative risk of representation to the same clinic with symptomatic P. vivax malaria within 6 months
Time frame: 18 months
Costs of implementing policy from a healthcare provider perspective, including health systems strengthening processes
Time frame: 18 months
Household costs per P. vivax episode
Time frame: 3 days
Overall cost-effectiveness of changing policy if revised case management is effective
Time frame: 18 months
Cost per episode of P. vivax malaria from the healthcare provider and societal perspectives
Time frame: 18 months
Cost per component of the revised case management package
Time frame: 18 months
If revised case management package is effective (significantly reduces the incidence of malaria), then the cost-effectiveness of implementing the revised case management as compared with usual care
Time frame: 18 months
Proportion of CHWs who correctly act on early signs of haemolytic anaemia and GI events (i.e. refer patients for further medical review, instruct patient to discontinue treatment)
Time frame: 3 days
Number of patients with an SAE who are identified by community or clinic staff follow-up and referred to hospital for further management
Time frame: During treatment (up to 8 weeks)
The proportion of patients eligible to receive PQ who had a SAE during treatment
Time frame: During treatment (up to 8 weeks)
Prevalence of severe anaemia in patients presenting with fever before and after implementation
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 42326839Fransisca L, Ome-Kaius M, Laman M, Poespoprodjo JR, Pasaribu AP, Sutanto I, Malai M, Nelwan E, Adella J, Abegini C, Ainur F, Amdara Y, Angeline S, Brown K, Burdam FH, Curry E, Daimen M, Daly P, Do T, Dori A, Douglas NM, Huegel H, Hutagalung AP, Jambert E, Jimanto V, Karo V, Kenangalem E, Kelebi T, Kisomb J, Laksono I, Lee G, Ley B, Mannion K, Plinduo J, Pukai I, Putri A, Rajasekhar M, Ronkentou S, Rosens E, Sakalidis VS, Satyagraha A, Simpson JA, Theodora M, Ubra R, Vakore N, Wansom T, Duparc S, Robinson LJ, Price RN. High-dose, short-course primaquine after point-of-care G6PD testing for the radical cure of Plasmodium vivax malaria: a safety study in Papua New Guinea and Indonesia. Lancet Reg Health West Pac. 2026 Jun 11;71:101903. doi: 10.1016/j.lanwpc.2026.101903. eCollection 2026 Jun.
- Results publication: PubMed 40670924SCOPE Study Group. High daily dose Short COurse PrimaquinE after G6PD testing for the radical cure of Plasmodium vivax malaria in Indonesia and Papua New Guinea: the SCOPE implementation study protocol. BMC Infect Dis. 2025 Jul 16;25(1):922. doi: 10.1186/s12879-025-11109-9.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan will be made available to others. The results will be published in peer-reviewed open access journals and disseminated to stakeholders. De-identified quantitative data for the purposes of confirming risk of adverse events will be available to researchers who provide a methodological sound proposal that is in line with the aims of the approved protocol.
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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. This study is not recruiting at the moment.
Moses Laman, Dr principal investigator
Papua New Guinea Institute of Medical Research
Leanne Robinson, Prof principal investigator
Macfarlane Burnet Institute for Medical Research and Public Health
Leo Makita principal investigator
National Department of Health, Papua New Guinea
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revised case management package in people with Vivax Malaria and G6PD Deficiency, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 4 sites in Papua New Guinea.
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 1 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: finished, as of the sponsor's last update on 2 Sep 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. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment. (time frame: During treatment (up to 8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05874271, which also lists 2 linked publications.
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 2 Sep 2026.