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_01 U1111-1291-3218
Description
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.
Trial arms
Trial start
2023-08-07
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 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
Arms:
Revised case management package
Size
11250
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', 'interventionModelDescription': 'Combination Product: Revised case management package', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11250, 'type': 'ESTIMATED'}}
Updated at
2024-02-05
1 organization
1 product
2 indications
Organization
Menzies School of Health ResearchIndication
Malaria caused by Plasmodium vivax