- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879224
Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia (SCOPE)
Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 allow 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 Indonesian Ministry 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 vivax malaria. These interventions are 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 six sites in Indonesia; four in Papua, one in North Sumatra and one in Lampung. We will use a staged approach for the implementation of the revised case management strategy, including patient education and counselling,community-based clinical review, with mixed methods evaluation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vanessa Sakalidis, PhD
- Phone Number: +614 08 8946 8600
- Email: vanessa.sakalidis@menzies.edu.au
Study Locations
-
-
Lampung
-
Hanura, Lampung, Indonesia
- Recruiting
- Puskesmas Hanura
-
Contact:
- Inge Sutanto, MD
- Email: sutanto.inge@yahoo.com
-
Principal Investigator:
- Inge Sutanto, MD
-
-
North Sumatra
-
Labuhanbatu, North Sumatra, Indonesia
- Recruiting
- Puskesmas Tanjung Leidong
-
Contact:
- Ayodhia Pasaribu, MD
- Email: ayodhia@usu.ac.id
-
Principal Investigator:
- Ayodhia Pasaribu, MD
-
-
Papua
-
Mimika, Papua, Indonesia
- Recruiting
- Puskesmas Bhintuka
-
Contact:
- Jeanne R Poespoprodjo, MD
- Email: didot2266@yahoo.com
-
Principal Investigator:
- Jeanne R Poespoprodjo, MD
-
Mimika, Papua, Indonesia
- Recruiting
- Puskesmas Pasar Sentral
-
Contact:
- Jeanne R Poespoprodjo, MD
- Email: didot2266@yahoo.com
-
Principal Investigator:
- Jeanne R Poespoprodjo, MD
-
Mimika, Papua, Indonesia
- Recruiting
- Puskesmas Timika
-
Contact:
- Jeanne R Poespoprodjo, MD
- Email: didot2266@yahoo.com
-
Principal Investigator:
- Jeanne R Poespoprodjo, MD
-
Mimika, Papua, Indonesia
- Recruiting
- Puskesmas Wania
-
Contact:
- Jeanne R Poespoprodjo, MD
- Email: didot2266@yahoo.com
-
Principal Investigator:
- Jeanne R Poespoprodjo, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Revised case management package
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 days
|
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
|
During treatment (up to 8 weeks) ]
|
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
|
During treatment (up to 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
AESIs are collected during clinical review using a study-specific questionnaire
|
During treatment (up to 8 weeks)
|
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
|
During treatment (up to 8 weeks)
|
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
|
During treatment (up to 8 weeks)
|
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
|
1 day
|
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
|
6 months
|
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
|
1 day
|
Proportion of patients receiving a SD Biosensor G6PD test
Time Frame: 1 day
|
The outcome will be assessed from patients' enrolment data
|
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
|
The outcome will be assessed from patients' enrolment data
|
1 day
|
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
|
3 days
|
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
|
3 days
|
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
|
3 days
|
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
|
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
|
This will be assessed using stakeholder interviews and focus groups
|
18 months
|
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
|
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
|
This will be assessed using stakeholder interviews and focus groups
|
18 months
|
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
|
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
|
This will be assessed by comparing facility surveillance data before implementation with facility surveillance data after implementation
|
18 months
|
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
|
18 months
|
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
|
18 months
|
Household costs per P. vivax episode
Time Frame: 3 days
|
This will be assessed from a household cost survey on a subset of patients
|
3 days
|
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
|
18 months
|
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
|
18 months
|
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
|
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
|
This will be assessed from health system data collected throughout the study
|
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
|
This will be assessed from clinical review data and study-specific questionnaire
|
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)
|
This will be assessed by linking clinical review data, study specific questionnaire and SAE form
|
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)
|
This will be assessed by linking enrolment data, clinical review, study specific questionnaire and SAE form
|
During treatment (up to 8 weeks)
|
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
|
18 months
|
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
|
During treatment (up to 8 weeks) ]
|
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 7clinical review data
|
1 week
|
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
|
1 day
|
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
|
18 months
|
Local acceptability of the revised case management algorithms among patients, their families, and healthcare workers established
Time Frame: Day 3
|
This will be assessed using stakeholder interviews and focus groups
|
Day 3
|
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=200patients (per facility) after implementation
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ric Price, MD, Menzies School of Health Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Infections
- Hematologic Diseases
- Genetic Diseases, Inborn
- Vector Borne Diseases
- Anemia
- Parasitic Diseases
- Protozoan Infections
- Carbohydrate Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Malaria
- Malaria, Vivax
- Glucosephosphate Dehydrogenase Deficiency
Other Study ID Numbers
- MMV_PQ_21_01 U1111-1291-3218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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