Serology-guided radical treatment to reduce Plasmodium vivax relapses in Ethiopia and Madagascar
Serological Testing and Treatment for Plasmodium Vivax Malaria: a Cluster-Randomised Trial in Ethiopia and Madagascar
PHASE3 · London School of Hygiene and Tropical Medicine · NCT06923592
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 19200 (estimated) |
| Ages | 12 Months and up |
| Sex | All |
| Sponsor | London School of Hygiene and Tropical Medicine (other) |
| Locations | 2 sites (Addis Ababa and 1 other locations) |
| Trial ID | NCT06923592 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Addis Ababa and 1 other locations
- Armauer Hansen Research Institute — Addis Ababa, Ethiopia (NOT_YET_RECRUITING)
- Institut Pasteur de Madagascar — Antananarivo, Madagascar (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malaria Vivax, Malaria Falciparum, Plasmodium Vivax, Plasmodium Falciparum, Plasmodium vivax, Vivax, PvSeroTAT, PvSTATEM