[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492338":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":12,"maxAge":12,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control: Standard Interventions","NO_INTERVENTION","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\u002Fkg on days 1 and 2, followed by 5 mg\u002Fkg on day 3) + PQ (0.5mg\u002Fkg x 7 days).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Focal Mass Drug Administration (fMDA)","EXPERIMENTAL","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.",[18],"Drug: Focal Mass Drug Administration (fMDA)",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"DRUG","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.\n\nEach year will include 2 rounds of fMDA.\n\nRound 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 \\\u003C16y (CQ: age-based dosing, PQ age-based dosing); CQ+PQ for G6PD intermediate individuals \\>=6mo and \\\u003C16y ((CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg, PQ age-based dosing).\n\nRound 2) single dose CQ+TQ for \\>= 16y (CQ: Day1 600 mg, TQ 300 mg on Day 1); single dose CQ+PQ for \\\u003C16y (CQ: age-based dosing, PQ age-based dosing); single dose CQ+PQ for G6PD intermediate individuals \\>=6mo and \\\u003C16y ((CQ: Day1 600 mg, PQ age-based dosing).",[14],[25,28],{"name":26,"affiliation":5,"role":27},"Michelle Hsiang, MD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Alejandro Llanos-Cuentas, MD, PhD","Universidad Peruana Cayetano Heredia",[32],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Sydney Fine, MPH","CONTACT","415-476-5494","sydney.fine@ucsf.edu",[38],{"facility":39,"status":40,"city":41,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Asociación Civil Selva Amazónica","RECRUITING","Iquitos","Peru","PE",{"type":45,"coordinates":46},"Point",[47,48],-73.2529,-3.74814,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":12,"phoneExt":12,"email":53},"Veronica Soto Calle, MD, PhD","veronica.soto.c@upch.pe",{"type":55,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[57,58,60,62,64,66,69,72],{"name":30,"class":6},{"name":59,"class":6},"PATH",{"name":61,"class":6},"Stanford University",{"name":63,"class":6},"Oxford University Clinical Research Unit Indonesia",{"name":65,"class":6},"Menzies School of Health Research",{"name":67,"class":68},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":70,"class":71},"GlaxoSmithKline","INDUSTRY",{"name":73,"class":6},"Medicines for Malaria Venture","100492338","phase-3-focal-mass-drug-administration-for-vivax-malaria-elimination-100492338",false,"NCT05690841","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","FLAME","Inclusion Criteria:\n\n1. Cluster eligibility\n\n   * Within 8 hours transport of Iquitos\n   * Incidence \\\u003C250\u002F1000 and \\>2 cases year prior to trial\n   * Population size (\\\u003C650)\n2. Chloroquine (CQ) eligibility\n\n   * Resides in neighboring household but within 200 m of Pv index case in the past 2 years\n   * Age ≥6 months old\n   * Present for intervention\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥8 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n   * A child ≥6 months old and \\\u003C8 years old that has informed consent from their parents\n3. Tafenoquine (TQ) eligibility\n\n   * Eligible to receive CQ\n   * Age ≥16 years old\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥16 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n4. Primaquine eligibility\n\n   * Eligible to receive CQ and ineligible to receive TQ\n   * Age ≥6 months old\n   * Adult ≥18 years old that provides informed consent\n   * A child ≥8 years and \\\u003C18 years old that provides informed assent and has informed consent from their parents\n   * A child ≥6 months old and \\\u003C8 years old that has informed consent from their parents\n5. Baseline evaluation and informed consent\n\n   -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\n6. Eligibility for fMDA\n\n   * 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\n   * 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.\n\nExclusion Criteria:\n\n1. Chloroquine eligibility\n\n   * History of retinal or visual field changes\n   * Known hypersensitivity or adverse reaction to CQ\n   * Currently taking CQ or have taken CQ in the past four weeks\n   * Ineligible for TQ or PQ (see criteria below)\n   * Hemoglobin \\\u003C9 g\u002FdL\n2. Tafenoquine eligibility\n\n   * G6PD deficiency or intermediate status (defined as activity ≤6.0 UI\u002FgHb per SD biosensor)\n   * G6PD status unknown or refusal of G6PD status test\n   * Acute or severe malaria\n   * Pregnancy (known or identified by pregnancy test)\n   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks\n   * Woman breastfeeding a child that is G6PD deficient or with unknown G6PD status\n   * Known hypersensitivity or adverse reaction to TQ or PQ\n   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks\n   * Hemoglobin \\\u003C 9 g\u002FdL\n3. Primaquine eligibility\n\n   * G6PD deficiency (defined as activity ≤4.0 UI\u002FgHb per SD biosensor)\n   * G6PD status unknown or refusal of G6PD status test\n   * Acute or severe malaria\n   * Pregnancy (known or identified by pregnancy test)\n   * Refusal of pregnancy test if new amenorrhea in the past 4 weeks\n   * Breastfeeding child with documented or unknown G6PD deficiency status\n   * Woman breastfeeding a child with documented or unknown G6PD deficiency status\n   * Known hypersensitivity or adverse reaction to TQ or PQ\n   * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks\n   * Hemoglobin \\\u003C 9 g\u002FdL",true,"ALL",{"count":85,"type":86},7530,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","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.",[92,93],"Plasmodium Vivax Malaria","Malaria",[95,96,97,98,99],"Antimalarial drugs","Primaquine","Chloroquine","Tafenoquine","Parasitic disease","2026-06-05",{"date":102,"type":103},"2026-06-09","ACTUAL",{"date":105,"type":103},"2024-10-14",{"date":107,"type":86},"2027-05-01",{"name":5,"class":6},1]