FocaL Mass Drug Administration for Vivax Malaria Elimination

• Status: Not yet recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Eijkman Oxford Clinical Research Unit, Indonesia; Menzies School of Health Research; National Institute of Allergy and Infectious Diseases (NIAID); PATH; Stanford University; Universidad Peruana Cayetano Heredia- subcontractor to UCSF as local Sponsor

Criteria

Inclusion Criteria:

1. Cluster eligibility

• Within 8 hours transport of Iquitos

• Incidence <500/1000 and >2 cases year prior to trial

• Population size (<1000)

2. Chloroquine (CQ) eligibility

• Resides in neighboring household but within 200 m of Plasmodium vivax index case in the past 2 years

• Age ≥6 months old

• Present for intervention

• Provides informed consent

3. Tafenoquine (TQ) eligibility

• Eligible to receive CQ

• Age ≥16 years old

• Provides informed consent

4. Primaquine eligibility

• Eligible to receive CQ and ineligible to receive TQ

• Age ≥6 months old

• Provides informed consent

5. Baseline evaluation and informed consent

-Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeks

6. Eligibility for fMDA

• High-risk villagers are defined as individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household) will be eligible to receive fMDA that study year in August and October.

• Villagers that were eligible but missed in the 1st annual round, or become eligible in the next two months, can receive fMDA in the 2nd annual round.

Exclusion Criteria:

1. Chloroquine eligibility

• Retinal or visual field changes

• Known hypersensitivity or adverse reaction to CQ

• Currently taking CQ

• Ineligible for TQ or PQ

2. Tafenoquine eligibility

• Glucose 6 phosphate dehydrogenase (G6PD) deficiency (defined as activity <70% per SD biosensor)

• G6PD status unknown or refusal of G6PD status test

• Acute illness or severe malaria

• Pregnancy (known or identified by pregnancy test)

• Refusal of pregnancy test if 14 years of age and female

• Breastfeeding child that is G6PD deficient or with unknown G6PD status

• Known hypersensitivity or adverse reaction to TQ or PQ

• Currently taking mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial

3. Primaquine eligibility

• G6PD deficiency (defined as activity <70% per SD biosensor)

• G6PD status unknown or refusal of G6PD status test

• Acute illness or severe malaria

• Pregnancy (known or identified by pregnancy test)

• Refusal of pregnancy test if 14 years of age and female

• Breastfeeding child that is G6PD deficient or with unknown G6PD status

• Known hypersensitivity or adverse reaction to TQ or PQ

• Currently taking mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial