Short course treatment for P. vivax malaria in Indonesia
Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria
This study is testing a new way to treat P. vivax malaria in Indonesia by using quick G6PD testing and a short course of medication to see if it helps patients get better safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11250 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Menzies School of Health Research Academic / other |
| Locations | 6 sites (Hanura, Lampung and 5 other locations) |
| Trial ID | NCT05879224 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment for patients with vivax malaria in Indonesia. It aims to address the challenges of treating P. vivax, which can form dormant liver stages and is associated with risks for individuals with G6PD deficiency. The study will be conducted at six health facilities across Indonesia using a before-and-after design, incorporating patient education, surveillance, and pharmacovigilance to enhance treatment adherence and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with vivax malaria who do not have contraindications such as pregnancy or severe anemia.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of adverse reactions to primaquine will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the treatment outcomes for patients with vivax malaria, reducing the burden of the disease.
How similar studies have performed: While there have been studies on primaquine treatment, this specific approach combining G6PD testing and short-course regimens is innovative and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanura, Lampung and 5 other locations
- Puskesmas Hanura — Hanura, Lampung, Indonesia (Recruiting)
- Puskesmas Tanjung Leidong — Labuhanbatu, North Sumatra, Indonesia (Recruiting)
- Puskesmas Bhintuka — Mimika, Papua, Indonesia (Recruiting)
- Puskesmas Pasar Sentral — Mimika, Papua, Indonesia (Recruiting)
- Puskesmas Timika — Mimika, Papua, Indonesia (Recruiting)
- Puskesmas Wania — Mimika, Papua, Indonesia (Recruiting)
Study contacts
- Principal investigator: Ric Price, MD — Menzies School of Health Research
- Study coordinator: Vanessa Sakalidis, PhD
- Email: vanessa.sakalidis@menzies.edu.au
- Phone: +614 08 8946 8600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.