Serology-guided radical treatment to reduce Plasmodium vivax relapses in Ethiopia and Madagascar
Official title: Serological Testing and Treatment for Plasmodium Vivax Malaria: a Cluster-Randomised Trial in Ethiopia and Madagascar
Run by London School of Hygiene and Tropical Medicine · NCT06923592 · Data updated 2026-11-12
This project will use an antibody blood test to find people recently infected with P. vivax and give G6PD-tested patients primaquine plus a blood-stage antimalarial to try to prevent relapses in selected communities.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Months and up |
| Sex | All |
| Enrollment | 19200 (estimated) |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Locations | 2 sites (Addis Ababa and 1 other locations) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | April 28, 2027 |
| Study ends | April 28, 2027 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT06923592 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are residents older than 12 months in the selected clusters who can remain in the area for follow-up and agree to serology and G6PD testing and possible primaquine treatment.
✕Probably not a fit
People who test antibody-negative, who are G6PD deficient, who cannot take primaquine, or who live outside the selected clusters are unlikely to receive or benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a cluster-randomized, open-label Phase 3 trial in Ethiopia and Madagascar, 48 clusters (24 per country) are randomized to a serology-guided intervention (PvSeroTAT) or control. About 100–600 participants per cluster will have P. vivax serology at baseline and month 6, and those with recent-infection antibodies in intervention clusters will get G6PD testing followed by radical cure with primaquine (14 days 0.25 mg/kg in Ethiopia; 7 days 0.5 mg/kg in Madagascar) plus chloroquine or artesunate-amodiaquine as appropriate. Participants will be monitored for side effects and adherence during the first 7 days and will have hemoglobin measured to detect post-treatment hemolysis. Malaria incidence will be tracked by passive case detection for up to 18 months after the first intervention.
Why it matters
Potential benefit: If successful, targeting radical treatment to people with recent P. vivax exposure could reduce relapses, lower clinical malaria cases, and help accelerate elimination in these communities.
How similar studies have gone: Primaquine is an established radical cure for P. vivax, and small-scale pilot work using serology to target treatment has shown promise, but large cluster-randomized evidence for serology-guided approaches is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Institut Pasteur de Madagascar
Antananarivo, Madagascar Recruiting -
Armauer Hansen Research Institute
Addis Ababa, Ethiopia Not yet recruiting
Study contacts
- Principal investigator: Chris Drakeley — London School of Hygiene and Tropical Medicine
- Study coordinator: Rob W van der Pluijm
- Email: rvanderp@pasteur.fr
- Phone: 0033145688000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.