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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product, Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• Participant will remain in the study area for at least the next month.

• Participant is older than 12 months

Locations
Other Locations
Ethiopia
Armauer Hansen Research Institute
NOT_YET_RECRUITING
Addis Ababa
Madagascar
Institut Pasteur de Madagascar
RECRUITING
Antananarivo
Contact Information
Primary
Rob W van der Pluijm
rvanderp@pasteur.fr
0033145688000
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2027-04-28
Participants
Target number of participants: 19200
Treatments
Experimental: PvSeroTAT intervention
Other: Control arm
Related Therapeutic Areas
Sponsors
Collaborators: Armauer Hansen Research Institute (AHRI), Ethiopia, Institut Pasteur de Madagascar, Institut Pasteur
Leads: London School of Hygiene and Tropical Medicine

This content was sourced from clinicaltrials.gov