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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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

Other trials in Papua New Guinea

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.

  1. 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.

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

    1. 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
    1. 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
    1. 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
    2. Improved malariometric surveillance and pharmacovigilance to support wider scale use of the revised case management
Study groups in NCT05874271
Study groupRoleWhat they receive
Revised case management packageExperimentalNot 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.

  1. 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)

  2. 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)

  3. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. Proportion of patients receiving a SD Biosensor G6PD test

    The outcome will be assessed from patients' enrolment data

    Measured: 1 day

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. Household costs per P. vivax episode

    This will be assessed from a household cost survey on a subset of patients

    Measured: 3 days

  28. 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

  29. 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

  30. Cost per component of the revised case management package

    This will be assessed from health system data collected throughout the study

    Measured: 18 months

  31. 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

  32. 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

  33. 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)

  34. 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)

  35. 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.

  1. First posted24 May 2023
  2. Study start7 Aug 2023
  3. Primary completion25 Oct 2025
  4. Study completion25 Oct 2025

Resources

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)
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 42326839

  • SCOPE 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

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