Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar
NCT ID: NCT06923592
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
19200 participants
INTERVENTIONAL
2025-05-12
2027-04-28
Brief Summary
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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.
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Detailed Description
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Arm 1 (PvSeroTAT intervention) or Arm 2 (Control arm). Within each cluster, approximately 400 participants (range 100-600) will be enrolled, based on the trial's inclusion and exclusion criteria. At baseline (month 0) and month 6 serology for P. vivax infections will be performed in all study participants. In the clusters in the PvSeroTAT arm, participants with a positive P. vivax serology at baseline or month 6 will be approached for treatment. First G6PD enzyme activity will be measured. If the enzyme activity is normal and no other contra-indication for treatment are found, the participants will be treated with 7 days of primaquine 0.5mg/kg/day and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar). It is possible that a participant could receive a radical P. vivax treatment at both baseline (month 0) and month 6. Participants will be monitored for side effects and adherence during the first 7 days after the start of antimalarial treatments. In addition, blood samples will be taken to measure hemoglobin levels to monitor for post-treatment hemolysis.
In the clusters in both arms, the incidence of malaria will be monitored through passive case detection in health posts up to 18 months after the first intervention. All cases that are detected during the passive case detection will be treated according to the national guidelines.
At month 12 and month 18 of the study, a cross sectional survey will be conducted in all study clusters. Blood samples will be taken to determine the prevalence of P. vivax and P. falciparum through PCR assays.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PvSeroTAT intervention
PvSeroTAT
Two rounds (month 0 and month 6) of serological screening for antibodies against P. vivax in the blood of all eligible cluster inhabitants. In the clusters in the PvSeroTAT arm, participants with a positive P. vivax serology at baseline or month 6 will be treated with 7 days of primaquine 0.5mg/kg/day and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar).
Control arm
Control
Two rounds (month 0 and month 6) of serological screening for antibodies against P. vivax in the blood of a subset of eligible cluster inhabitants. Serological status will be assessed at a later stage (months later) and will not lead to treatment of sero-positive individuals.
Interventions
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PvSeroTAT
Two rounds (month 0 and month 6) of serological screening for antibodies against P. vivax in the blood of all eligible cluster inhabitants. In the clusters in the PvSeroTAT arm, participants with a positive P. vivax serology at baseline or month 6 will be treated with 7 days of primaquine 0.5mg/kg/day and a three-day course of either chloroquine (Ethiopia) or artesunate-amodiaquine (Madagascar).
Control
Two rounds (month 0 and month 6) of serological screening for antibodies against P. vivax in the blood of a subset of eligible cluster inhabitants. Serological status will be assessed at a later stage (months later) and will not lead to treatment of sero-positive individuals.
Eligibility Criteria
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Inclusion Criteria
* Participant is older than 12 months
Exclusion Criteria
12 Months
ALL
No
Sponsors
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Institut Pasteur
INDUSTRY
Institut Pasteur de Madagascar
OTHER
Armauer Hansen Research Institute (AHRI), Ethiopia
UNKNOWN
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Chris Drakeley
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Michael T White
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur
Rindra Randremanana
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur de Madagascar
Fitsum G Tadesse
Role: PRINCIPAL_INVESTIGATOR
Armauer Hansen Research Institute
Locations
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Armauer Hansen Research Institute
Addis Ababa, , Ethiopia
Institut Pasteur de Madagascar
Antananarivo, , Madagascar
Countries
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Central Contacts
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Facility Contacts
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Related Links
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PvSTATEM project website
Other Identifiers
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29643
Identifier Type: -
Identifier Source: org_study_id
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