FocaL Mass Drug Administration for Vivax Malaria Elimination

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 18, 2023

Keywords

ClinConnect Summary

The FLAME trial is studying a method called focal mass drug administration (fMDA) to help eliminate a type of malaria called Plasmodium vivax in certain areas of Peru. Researchers want to see if giving groups of people anti-malarial drugs can lower the number of new malaria cases compared to standard treatments, which include testing for malaria and providing insecticide-treated bed nets. This trial is currently looking for participants from villages near Iquitos, especially those living close to individuals who have had malaria in the past two years.

To be eligible, participants must be at least 6 months old and live within 200 meters of someone who had Plasmodium vivax malaria. They also need to be present during the treatment. Participants can expect to receive either the anti-malarial drugs or standard care based on their village's random assignment. It's important for potential participants to know that there are specific health criteria for joining, such as not having certain medical conditions or recent use of other malaria medications. Overall, this trial aims to find effective ways to reduce malaria in affected communities.

Gender

ALL

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
• • 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