Clinical trial
Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria
Name
MMV_PQ_21_02
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 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.
Trial arms
Trial start
2023-07-10
Estimated PCD
2025-05-31
Trial end
2025-07-31
Status
Recruiting
Treatment
Revised case management package
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
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
Arms:
Revised case management package
Size
5850
Primary endpoint
Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment.
During treatment (up to 8 weeks)
Proportion of patients experiencing at least one Adverse Event of Special Interest (AESI) during treatment.
During treatment (up to 8 weeks)
Proportion of patients with P. vivax malaria who correctly receive all components of the revised case management package
3 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5850, 'type': 'ESTIMATED'}}
Updated at
2023-07-11
1 organization
1 product
2 indications
Indication
Malaria caused by Plasmodium vivax