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Recruiting Phase 3 NCT05690841

FocaL Mass Drug Administration for Vivax Malaria Elimination

Trial Parameters

Condition Plasmodium Vivax Malaria
Sponsor University of California, San Francisco
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 7,530
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2024-10-14
Completion 2027-05-01
Interventions
Focal Mass Drug Administration (fMDA)

Brief Summary

FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.

Eligibility Criteria

Inclusion Criteria: 1. Cluster eligibility * Within 8 hours transport of Iquitos * Incidence \<250/1000 and \>2 cases year prior to trial * Population size (\<650) 2. Chloroquine (CQ) eligibility * Resides in neighboring household but within 200 m of Pv index case in the past 2 years * Age ≥6 months old * Present for intervention * Adult ≥18 years old that provides informed consent * A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents * A child ≥6 months old and \<8 years old that has informed consent from their parents 3. Tafenoquine (TQ) eligibility * Eligible to receive CQ * Age ≥16 years old * Adult ≥18 years old that provides informed consent * A child ≥16 years and \<18 years old that provides informed assent and has informed consent from their parents 4. Primaquine eligibility * Eligible to receive CQ and ineligible to receive TQ * Age ≥6 months old * Adult ≥18 years old that provides informed consent * A child ≥8 years a

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