Actively Recruiting

Phase 3
All Genders
Healthy Volunteers
NCT05690841

FocaL Mass Drug Administration for Vivax Malaria Elimination

Led by University of California, San Francisco · Updated on 2025-11-14

7530

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

Universidad Peruana Cayetano Heredia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

FocaL Mass Drug Administration for Vivax Malaria Elimination

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Cluster located within 8 hours transport of Iquitos
  • Malaria incidence between 2 and 250 cases per 1000 in the year prior to trial
  • Population size less than 650
  • Reside in a household within 200 meters of a Plasmodium vivax index case from the past 2 years
  • Age 6 months or older
  • Present for intervention
  • Adults 18 years or older who provide informed consent
  • Children 8 years and older and under 18 who provide assent and have parental consent
  • Children 6 months and under 8 years who have parental consent
  • High-risk villagers eligible to receive fMDA per cycle
  • Villagers who slept in a household in the study cluster at least one night in the past 4 weeks eligible for surveys
Not Eligible

You will not qualify if you...

  • History of retinal or visual field changes
  • Known allergy or adverse reaction to chloroquine
  • Currently taking or taken chloroquine in the past 4 weeks
  • Hemoglobin less than 9 g/dL
  • G6PD deficiency or intermediate status (per biosensor test)
  • Unknown or refused G6PD status test
  • Acute or severe malaria
  • Pregnancy or breastfeeding a child with unknown or deficient G6PD status
  • Refusal of pregnancy test if recent amenorrhea
  • Known allergy or adverse reaction to tafenoquine or primaquine
  • Taken mefloquine, tafenoquine, primaquine, or other antimalarials in past 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Asociación Civil Selva Amazónica

Iquitos, Peru

Actively Recruiting

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Research Team

S

Sydney Fine, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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