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FocaL Mass Drug Administration for Vivax Malaria Elimination
FocaL Mass Drug Administration for Vivax Malaria Elimination

NCT05690841

RecruitingPhase 3

Sponsor: University of California, San Francisco

Conditions: Plasmodium Vivax Malaria, Malaria

Interventions: Focal Mass Drug Administration (fMDA)

Countries: Peru

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 overview

Sex: ALL

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
   * 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
3. 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
4. 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
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 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.

Exclusion Criteria:

1. 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
   * Ineligible for TQ or PQ (see criteria below)
   * Hemoglobin \<9 g/dL
2. Tafenoquine eligibility

   * G6PD deficiency or intermediate status (defined as activity ≤6.0 UI/gHb per SD biosensor)
   * G6PD status unknown or refusal of G6PD status test
   * Acute or severe malaria
   * Pregnancy (known or identified by pregnancy test)
   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks
   * Woman breastfeeding a child that is G6PD deficient or with unknown G6PD status
   * Known hypersensitivity or adverse reaction to TQ or PQ
   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks
   * Hemoglobin \< 9 g/dL
3. Primaquine eligibility

   * G6PD deficiency (defined as activity ≤4.0 UI/gHb per SD biosensor)
   * G6PD status unknown or refusal of G6PD status test
   * Acute or severe malaria
   * Pregnancy (known or identified by pregnancy test)
   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks
   * Breastfeeding child with documented or unknown G6PD deficiency status
   * Woman breastfeeding a child with documented or unknown G6PD deficiency status
   * Known hypersensitivity or adverse reaction to TQ or PQ
   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks
   * Hemoglobin \< 9 g/dL
Locations (1)
  • Iquitos, Peru