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RECRUITINGPhase 3INTERVENTIONAL

FocaL Mass Drug Administration for Vivax Malaria Elimination

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form - A child ≥8 years and \<18 years old that provides informed assent and has willing to sign a consent form from their parents - A child ≥6 months old and \<8 years old that has willing to sign a consent form from their parents 3. Tafenoquine (TQ) eligibility - Eligible to receive CQ - Age ≥16 years old - Adult ≥18 years old that provides willing to sign a consent form - A child ≥16 years and \<18 years old that provides informed assent and has willing to sign a consent form 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 willing to sign a consent form - A child ≥8 years and \<18 years old that provides informed assent and has willing to sign a consent form from their parents - A child ≥6 months old and \<8 years old that has willing to sign a consent form from their parents 5. Baseline evaluation and willing to sign a consent form -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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Focal Mass Drug Administration (fMDA)

Administration of focal mass drug administration for high-risk 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). Intervention to be administered two times, two months apart each cycle, for 3 cycles spaced apart by regular intervals. Each year will include 2 rounds of fMDA. Round 1) Chloroquine (CQ)+ Tafenoquine (TQ) for \>= 16y (CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg CQ, TQ 300 mg on Day 1); CQ+ Primaquine (PQ) for \<16y (CQ: age-based dosing, PQ age-based dosing); CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg, PQ age-based dosing). Round 2) single dose CQ+TQ for \>= 16y (CQ: Day1 600 mg, TQ 300 mg on Day 1); single dose CQ+PQ for \<16y (CQ: age-based dosing, PQ age-based dosing); single dose CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, PQ age-based dosing).

Locations (1)

Asociación Civil Selva Amazónica
Iquitos, Peru