Short Course Primaquine for the Radical Cure of P. Vivax Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2025-12-17

Brief Summary

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The proportion of malaria that is the Plasmodium vivax species is increasing in Indonesia. Reducing vivax malaria will require innovative solutions to cure both the blood and liver stages of the disease. This study will evaluate of the feasibility of implementing point-of-care glucose-6-phosphate dehydrogenase deficiency (G6PD) testing. This will be followed by high dose, short course primaquine treatment regimens for patients with vivax malaria, and combined with patient education, surveillance, and pharmacovigilance. We plan to implement the study at 6 health facilities across Indonesia using a staged before-and-after study, with a mixed method evaluation.

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Detailed Description

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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.

Conditions

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Vivax Malaria G6PD Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Combination Product: Revised case management package

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Revised case management package

Group Type EXPERIMENTAL

Revised case management package

Intervention Type COMBINATION_PRODUCT

1. Point-of-care quantitative G6PD testing using G6PDSTANDARD (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 G6PDactivity is 30-70 percent
* PQ8w (0.75 mg/kg/week for 8 weeks) if G6DPactivity less than 30 percent
3. Participant counselling at the health facility (Day 0):

* Supervision of first dose of primaquine
* Education regarding the 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

Interventions

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Revised case management package

1. Point-of-care quantitative G6PD testing using G6PDSTANDARD (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 G6PDactivity is 30-70 percent
* PQ8w (0.75 mg/kg/week for 8 weeks) if G6DPactivity less than 30 percent
3. Participant counselling at the health facility (Day 0):

* Supervision of first dose of primaquine
* Education regarding the 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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No