FocaL Mass Drug Administration for Vivax Malaria Elimination
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco
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 monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.
Eligibility criteria
Qualifiers
Cluster eligibility
Within 8 hours transport of Iquitos
Incidence <250/1000 and >2 cases year prior to trial
Population size (<650)
Disqualifiers
Chloroquine eligibility
History of retinal or visual field changes
Known hypersensitivity or adverse reaction to CQ
Currently taking CQ or have taken CQ in the past four weeks
Trial design
Treatments tested in this trial
- Focal Mass Drug Administration (fMDA)
Treatment groups
7,530 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
Universidad Peruana Cayetano Heredia
Collaborator
PATH
Collaborator
Stanford University
Collaborator
Oxford University Clinical Research Unit Indonesia
Collaborator
Menzies School of Health Research
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
GlaxoSmithKline
Collaborator
Medicines for Malaria Venture
Collaborator
Source ClinicalTrials.gov