NCT06923592 Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar
| NCT ID | NCT06923592 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | London School of Hygiene and Tropical Medicine |
| Condition | Malaria Vivax |
| Study Type | INTERVENTIONAL |
| Enrollment | 19,200 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2027-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 19,200 participants in total. It began in 2025-05-12 with a primary completion date of 2027-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The resilience of P. vivax to malaria elimination efforts is due to its ability to form dormant liver stages (hypnozoites) that reactivate weeks to months after the initial infection causing recurrent episodes of malaria (relapses) and ongoing parasite transmission. Relapses account for a majority of recurrent infections and clinical cases of P. vivax malaria, and therefore have a significant effect on morbidity at the individual level. With current technology, it is not possible to directly measure hypnozoite biomarkers. Rather than directly detecting hypnozoites, our team developed an indirect approach by measuring antibodies induced by the primary blood-stage infection. Antibodies to different blood-stage antigens decay at different rates. Measuring antibodies to a carefully selected panel of P. vivax antigens can aid to identify individuals who have been infected within the previous 9 months (approximately the lifespan of hypnozoites). A serological test based on selected P. vivax antigens can detect recent exposure and predict future relapses. Coupling this test with a safe and efficacious primaquine treatment regimen, results in a population-based intervention to target the hypnozoite reservoir. This intervention is referred to as Plasmodium vivax Serological Testing and Treatment (PvSeroTAT). PvSTATEM is a cluster randomised trial in Madagascar and Ethiopia. This study will provide insights into the feasibility, acceptability, and efficacy of the PvSeroTAT approach. In this study, individuals, randomised by clusters, will be tested for the presence of serological markers of a recent P. vivax infection, followed by a targeted drug treatment intervention aimed at killing P. vivax hypnozoites.
Eligibility Criteria
Inclusion Criteria: * Participant will remain in the study area for at least the next month. * Participant is older than 12 months Exclusion Criteria: • Participant is unwilling to participate.
Contact & Investigator
Chris Drakeley
PRINCIPAL INVESTIGATOR
London School of Hygiene and Tropical Medicine
Frequently Asked Questions
Who can join the NCT06923592 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, studying Malaria Vivax. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06923592 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 19,200 participants.
Is NCT06923592 currently recruiting?
Yes, NCT06923592 is actively recruiting participants. Contact the research team at rvanderp@pasteur.fr for enrollment information.
Where is the NCT06923592 trial being conducted?
This trial is being conducted at Addis Ababa, Ethiopia, Antananarivo, Madagascar.
Who is sponsoring the NCT06923592 clinical trial?
NCT06923592 is sponsored by London School of Hygiene and Tropical Medicine. The principal investigator is Chris Drakeley at London School of Hygiene and Tropical Medicine. The trial plans to enroll 19,200 participants.