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Completed

NCT Number: NCT05874271

Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea

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 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.

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Key information

Conditions

Vivax Malaria Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities G6PD Deficiency Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria Malaria, Vivax Metabolic Diseases Metabolism, Inborn Errors Mosquito-Borne Diseases Nutritional and Metabolic Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Napapar Health Centre, Kokopo, East New Britain Province, Papua New Guinea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with vivax malaria

Exclusion criteria

  • 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

Treatment and study plan

Revised case management package

Combination 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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. The proportion of patients with any AESI during treatment

    Time frame: During treatment (up to 8 weeks)

    AESIs are collected during clinical review using a study-specific questionnaire

  2. The proportion of patients with a gastrointestinal (GI) AESI during treatment

    Time frame: During treatment (up to 8 weeks)

    AESIs are collected during clinical review using a study-specific questionnaire

  3. The proportion of patients with an AESI related to haemolysis during treatment

    Time frame: During treatment (up to 8 weeks)

    AESIs are collected during clinical review using a study-specific questionnaire

  4. The proportion of patients an AESI related to methaemoglobinaemia

    Time frame: During treatment (up to 8 weeks)

    AESIs are collected during clinical review using a study-specific questionnaire

  5. Proportion of patients permanently stopping PQ before end of treatment

    Time frame: During treatment (up to 8 weeks)

    Discontinuation of PQ will be assessed using a study-specific questionnaire

  6. The proportion of patients receiving correct treatment based on G6PD activity

    Time frame: 1 day

    This will be assessed by linking patients G6PD activity results measured during study enrolment with primaquine dose prescribed on the same day

  7. Proportion of patients who were reviewed on Day 3 and Day 7

    Time frame: 1 week

    This will be assessed by linking patients enrolment data with Day 3 and Day 7 clinical review data

  8. Perception of and experience with new radical cure tools among health care providers and community members

    Time frame: 6 months

    This will be assessed using stakeholder interviews

  9. Proportion of health care practitioners who comply with the revised radical cure treatment algorithm

    Time frame: 1 day

    The outcome will be assessed from patients' enrolment data

  10. Proportion of patients receiving a SD Biosensor G6PD test

    Time frame: 1 day

    The outcome will be assessed from patients' enrolment data

  11. 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

    The outcome will be assessed from patients' enrolment data

  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)

    Time frame: 1 day

    The outcome will be assessed from patients' enrolment data

  13. Proportion of P. vivax malaria patients that are reviewed on Day 3

    Time frame: 3 days

    This will be assessed by linking patients' enrolment data with clinical review data

  14. Proportion of P. vivax malaria patients that adhere to their prescribed primaquine regimen

    Time frame: 3 days

    This will be assessed by linking patients' enrolment data with clinical review data

  15. Factors influencing acceptability and feasibility of the new radical cure tools among health care providers are identified

    Time frame: 3 days

    This will be assessed using stakeholder interviews, observations and focus groups

  16. Barriers and enablers of uptake and implementation at the sub-national levels are identified

    Time frame: 18 months

    This will be assessed using stakeholder interviews and focus groups

  17. 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

    This will be assessed using stakeholder interviews and focus groups

  18. Required knowledge, skills, and training to administer the revised case management and patient-counselling identified

    Time frame: 18 months

    This will be assessed using stakeholder interviews and focus groups

  19. Factors influencing the barriers and facilitators to patient adherence to primaquine after the rollout of the revised case management identified

    Time frame: 18 months

    This will be assessed using stakeholder interviews and focus groups

  20. Factors influencing the acceptability and feasibility of community-based clinical review at Day 3 of primaquine treatment identified.

    Time frame: 18 months

    This will be assessed using stakeholder interviews and focus groups

  21. Perceptions of the new radical cure tools and serious adverse events at the community level identified

    Time frame: 18 months

    This will be assessed using stakeholder interviews and focus groups

  22. Local acceptability of the revised case management algorithms among patients, their families, and healthcare workers established

    Time frame: 18 months

    This will be assessed using stakeholder interviews and focus groups

  23. The monthly incidence of confirmed symptomatic P. vivax malaria episodes (mono-infection or mixed) before implementation versus after implementation

    Time frame: 18 months

    This will be assessed by comparing facility surveillance data before implementation with facility surveillance data after implementation

  24. The prevalence of P. vivax parasitaemia in patients presenting with fever before implementation versus after implementation

    Time frame: 18 months

    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

  25. Cumulative risk of representation to the same clinic with symptomatic P. vivax malaria within 6 months

    Time frame: 18 months

    This will be assessed by linking patients' enrolment data

  26. Costs of implementing policy from a healthcare provider perspective, including health systems strengthening processes

    Time frame: 18 months

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

  27. Household costs per P. vivax episode

    Time frame: 3 days

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

  28. Overall cost-effectiveness of changing policy if revised case management is effective

    Time frame: 18 months

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

  29. Cost per episode of P. vivax malaria from the healthcare provider and societal perspectives

    Time frame: 18 months

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

  30. Cost per component of the revised case management package

    Time frame: 18 months

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

  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

    Time frame: 18 months

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

  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)

    Time frame: 3 days

    This will be assessed from clinical review data and study-specific questionnaire

  33. 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)

    This will be assessed by linking clinical review data, study specific questionnaire and SAE form

  34. The proportion of patients eligible to receive PQ who had a SAE during treatment

    Time frame: During treatment (up to 8 weeks)

    This will be assessed by linking enrolment data, clinical review, study specific questionnaire and SAE form

  35. Prevalence of severe anaemia in patients presenting with fever before and after implementation

    Time frame: 18 months

    This will be assessed by comparing the facility surveillance data before implementation with facility surveillance data after implementation

Sponsors and collaborators

Lead sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Other

Collaborators

  • Medicines for Malaria Venture
  • Menzies School of Health Research
  • PATH
  • Papua New Guinea Institute of Medical Research
  • Papua New Guinea National Department of Health
  • UNITAID
  • University of Melbourne

Registry information

Official study title

Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria

Acronym: SCOPE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 24, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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