FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• Cluster eligibility

‣ Within 8 hours transport of Iquitos

⁃ Incidence \<250/1000 and \>2 cases year prior to trial

⁃ Population size (\<650)

• 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

• 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

• 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 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

• 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

• 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 cycle

⁃ Villagers that were eligible but missed in the 1st round in a cycle, or become eligible in the next two months, will not be eligible to receive fMDA in the 2nd round in a cycle.

Locations
Other Locations
Peru
Asociación Civil Selva Amazónica
RECRUITING
Iquitos
Contact Information
Primary
Sydney Fine, MPH
sydney.fine@ucsf.edu
415-476-5494
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 7530
Treatments
No_intervention: Control: Standard Interventions
Standard interventions for the control cluster will include providing participants with long-lasting insecticide-treated bednets, management of known and possible mosquito breeding sites, passive case detection through detection and diagnosis of symptomatic cases of malaria in health facilities and through community health workers (conducted in villagers with fever), microscopy testing in households of recent index cases to detect asymptomatic malaria cases, and treatment of active cases of malaria (artesunate-mefloquine (AS-MQ) for Plasmodium falciparum and Chloroquine (CQ) (10 mg/kg on days 1 and 2, followed by 5 mg/kg on day 3) + PQ (0.5mg/kg x 7 days).
Experimental: Focal Mass Drug Administration (fMDA)
Standard interventions in addition to focal mass drug administration. Focal mass drug administration will include using primaquine, chloroquine, and tafenoquine, for high-risk individuals residing in households that are within 200 meters of a Plasmodium vivax (Pv) index case households from the prior 2 years (including individuals in the index case household). Pv index cases include symptomatic cases detected at health facilities or in fever screenings, and asymptomatic cases identified during routine active case detection by health facilities. Households will then be notified regarding their potential to receive two rounds fMDA that cycle. Eligibility to receive medications as part of fMDA will be assessed prior to each administration and include glucose 6 phosphate dehydrogenase (G6PD) testing and counseling if not previously conducted or result is not available on the participant's identification card.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), PATH, Stanford University, Oxford University Clinical Research Unit Indonesia, Menzies School of Health Research, Universidad Peruana Cayetano Heredia- subcontractor to UCSF as local Sponsor
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov