FocaL Mass Drug Administration for Vivax Malaria Elimination
Recruiting
Phase 3
Interventional Study
Plasmodium Vivax Malaria
Malaria
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 7,530 (estimated)
- Sponsor
- University of California, San Francisco · Other
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About This Trial
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 mon…
Trial Locations
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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
…
Contacts