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Recruiting NCT06923592

Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar

Conditions: Malaria Vivax, Malaria Falciparum, Plasmodium Vivax, Plasmodium Falciparum

Sex: All
Ages: 12 Months – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 19200
Sponsor: London School of Hygiene and Tropical Medicine

Location: Armauer Hansen Research Institute Addis Ababa

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06923592). StuddyBuddy aggregates publicly available trial information.