[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523309":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":491,"collaborators":30,"id":493,"slug":30,"hasResults":494,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":494,"sex":500,"minAge":501,"maxAge":502,"enrollmentInfo":503,"targetDuration":30,"studyType":506,"phases":507,"briefSummary":509,"conditions":510,"keywords":30,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":521},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Baloxavir Marboxil","EXPERIMENTAL","Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age). HHCs related to IPs will be enrolled but will not receive treatment.",[13],"Drug: Baloxavir Marboxil",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms \\[kg\\]: 80 milligrams \\[mg\\]; ≥20 kg to \\\u003C 80 kg: 40 mg; \\\u003C20 kg: 2 milligrams per kilogram \\[mg\u002Fkg\\]).",[9],[20],"XOFLUZA®; RO7191686",[22],{"name":23,"affiliation":5,"role":24},"Clinical Trials","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Reference Study ID Number: CV44536 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. Only)",null,"global-roche-genentech-trials@gene.com",[33,46,56,66,75,86,95,105,115,125,135,145,153,163,173,183,192,202,212,222,231,240,246,253,262,268,277,287,298,308,317,326,332,341,350,359,365,375,381,390,399,408,417,426,435,438,447,456,467,476,482],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":30},"Central Alabama Research","RECRUITING","Birmingham","Alabama","35209","United States",{"type":41,"coordinates":42},"Point",[43,44],-86.80249,33.52066,{"lat":44,"lon":43},{"facility":47,"status":35,"city":48,"state":49,"zip":50,"country":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":30},"Harrisburg Family Medical Center","Harrisburg","Arkansas","72432",{"type":41,"coordinates":52},[53,54],-90.71678,35.56425,{"lat":54,"lon":53},{"facility":57,"status":35,"city":58,"state":59,"zip":60,"country":39,"cosmosGeoPoint":61,"geoPoint":65,"contacts":30},"Kendall South Medical Center Inc.","Miami","Florida","33185",{"type":41,"coordinates":62},[63,64],-80.19366,25.77427,{"lat":64,"lon":63},{"facility":67,"status":35,"city":68,"state":59,"zip":69,"country":39,"cosmosGeoPoint":70,"geoPoint":74,"contacts":30},"Avanza Medical Research Center","Pensacola","32503",{"type":41,"coordinates":71},[72,73],-87.21691,30.42131,{"lat":73,"lon":72},{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":39,"cosmosGeoPoint":81,"geoPoint":85,"contacts":30},"Tekton Research - 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Saint George","3403",{"type":41,"coordinates":330},[323,324],{"lat":324,"lon":323},{"facility":333,"status":97,"city":334,"state":30,"zip":335,"country":302,"cosmosGeoPoint":336,"geoPoint":340,"contacts":30},"SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.","Rousse","7002",{"type":41,"coordinates":337},[338,339],25.9534,43.84872,{"lat":339,"lon":338},{"facility":342,"status":35,"city":343,"state":30,"zip":344,"country":302,"cosmosGeoPoint":345,"geoPoint":349,"contacts":30},"MHAT Sliven - Military Medial Academy","Sliven","8800",{"type":41,"coordinates":346},[347,348],26.32558,42.68607,{"lat":348,"lon":347},{"facility":351,"status":35,"city":352,"state":30,"zip":353,"country":302,"cosmosGeoPoint":354,"geoPoint":358,"contacts":30},"AGPSMP Pediatric diseases South park OOD","Sofia","1421",{"type":41,"coordinates":355},[356,357],23.32415,42.69751,{"lat":357,"lon":356},{"facility":360,"status":97,"city":352,"state":30,"zip":361,"country":302,"cosmosGeoPoint":362,"geoPoint":364,"contacts":30},"Medical Center Hera Sofia","1510",{"type":41,"coordinates":363},[356,357],{"lat":357,"lon":356},{"facility":366,"status":35,"city":367,"state":30,"zip":368,"country":369,"cosmosGeoPoint":370,"geoPoint":374,"contacts":30},"IN VIVO Sp. z o.o.","Bydgoszcz","85-048","Poland",{"type":41,"coordinates":371},[372,373],18.00762,53.1235,{"lat":373,"lon":372},{"facility":376,"status":35,"city":367,"state":30,"zip":377,"country":369,"cosmosGeoPoint":378,"geoPoint":380,"contacts":30},"NZOZ Vitamed","85-079",{"type":41,"coordinates":379},[372,373],{"lat":373,"lon":372},{"facility":382,"status":35,"city":383,"state":30,"zip":384,"country":369,"cosmosGeoPoint":385,"geoPoint":389,"contacts":30},"Centrum Medyczne Pratia Częstochowa","Częstochowa","42-200",{"type":41,"coordinates":386},[387,388],19.12409,50.79646,{"lat":388,"lon":387},{"facility":391,"status":35,"city":392,"state":30,"zip":393,"country":369,"cosmosGeoPoint":394,"geoPoint":398,"contacts":30},"Niepubliczny Zaklad Opieki Zdrowotnej \"Amed\"","Grójec","05-600",{"type":41,"coordinates":395},[396,397],20.86757,51.86252,{"lat":397,"lon":396},{"facility":400,"status":35,"city":401,"state":30,"zip":402,"country":369,"cosmosGeoPoint":403,"geoPoint":407,"contacts":30},"Vita Longa Sp. z o.o.","Katowice","40-748",{"type":41,"coordinates":404},[405,406],19.02173,50.2597,{"lat":406,"lon":405},{"facility":409,"status":97,"city":410,"state":30,"zip":411,"country":369,"cosmosGeoPoint":412,"geoPoint":416,"contacts":30},"Centrum Medyczne K2J2","Lodz","92-108",{"type":41,"coordinates":413},[414,415],19.47395,51.77058,{"lat":415,"lon":414},{"facility":418,"status":35,"city":419,"state":30,"zip":420,"country":369,"cosmosGeoPoint":421,"geoPoint":425,"contacts":30},"NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska","Siemianowice Śląskie","41-103",{"type":41,"coordinates":422},[423,424],19.02901,50.32738,{"lat":424,"lon":423},{"facility":427,"status":35,"city":428,"state":30,"zip":429,"country":369,"cosmosGeoPoint":430,"geoPoint":434,"contacts":30},"Jaroslaw Kierkus Prywatna Prakyka Lekarska","Warsaw","04-501",{"type":41,"coordinates":431},[432,433],21.01178,52.22977,{"lat":433,"lon":432},{"facility":409,"status":77,"city":436,"state":30,"zip":437,"country":369,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Wo?omin","05-200",{"facility":439,"status":35,"city":440,"state":30,"zip":441,"country":369,"cosmosGeoPoint":442,"geoPoint":446,"contacts":30},"Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?","Wroclaw","53-149",{"type":41,"coordinates":443},[444,445],17.03006,51.10286,{"lat":445,"lon":444},{"facility":448,"status":35,"city":449,"state":30,"zip":450,"country":369,"cosmosGeoPoint":451,"geoPoint":455,"contacts":30},"NZOZ Salmed","Łęczna","21-010",{"type":41,"coordinates":452},[453,454],22.88135,51.30121,{"lat":454,"lon":453},{"facility":457,"status":77,"city":458,"state":459,"zip":460,"country":461,"cosmosGeoPoint":462,"geoPoint":466,"contacts":30},"Complejo Hospitalario Universitario de Santiago (CHUS)","Santiago de Compostela","LA Coruna","15706","Spain",{"type":41,"coordinates":463},[464,465],-8.54569,42.88052,{"lat":465,"lon":464},{"facility":468,"status":77,"city":469,"state":30,"zip":470,"country":461,"cosmosGeoPoint":471,"geoPoint":475,"contacts":30},"Hospital Infantil Universitario Nino Jesus","Madrid","28009",{"type":41,"coordinates":472},[473,474],-3.70256,40.4165,{"lat":474,"lon":473},{"facility":477,"status":77,"city":469,"state":30,"zip":478,"country":461,"cosmosGeoPoint":479,"geoPoint":481,"contacts":30},"Hospital Universitario 12 de Octubre","28041",{"type":41,"coordinates":480},[473,474],{"lat":474,"lon":473},{"facility":483,"status":97,"city":484,"state":30,"zip":485,"country":461,"cosmosGeoPoint":486,"geoPoint":490,"contacts":30},"Hospital Universitari i Politècnic La Fe","Valencia","46026",{"type":41,"coordinates":487},[488,489],-0.37966,39.47391,{"lat":489,"lon":488},{"type":492,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100523309",false,"NCT06094010","A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts","A Phase IIIb Multicenter, Single-arm, Open-label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts","Pebblestone","Inclusion Criteria (Part A):\n\n* Participants with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening\n* Participants with a negative severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 48 hours before full study screening\n* Time interval between onset of influenza symptoms and the start of pre-dose examinations at screening is 48 hours or less\n\nInclusion Criteria (Part B):\n\n\\[A\\] IP:\n\n* Eligible to take part in Part A\n* Lives in a household with a HHC willing to be recruited as full HHC\n\n\\[B\\] HHCs:\n\n\\- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility\n\n\\[C\\] Partial HHC:\n\n* Starts screening within 1 calendar day after IP treatment\n* Negative influenza and SARS-CoV-2 test at screening after IP's treatment with baloxavir marboxil\n* HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements AND at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening\n* HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements, and at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening.\n* HHC lives with other HHCs (if applicable) who fulfill all the \"partial HHC\" criteria\n\n\\[D\\] Full-study HHC:\n\n* Fulfills the \"partial HHC\" criteria\n* Agrees to participate in the full study\n* Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits\n* No influenza symptoms within 7 days prior to screening\n* Does not have a moderate or worse active infections or infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic\u002Fantiviral\u002Fantifungal therapy\n\nExclusion Criteria (Part A):\n\n* Participants with severe influenza virus infection requiring inpatient treatment\n* Severely immunocompromised participants (including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus \\[HIV\\] infection) as defined by the investigator\n* Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and\u002For anti-viral therapy at the pre-dose examinations\n* Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening\n* Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening\n* Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening\n* Known hypersensitivity to baloxavir marboxil or the drug product excipients\n* Females who have commenced menarche (i.e., child-bearing potential)\n\nExclusion Criteria (Part B):\n\n* IPs who fulfil an exclusion criterion for Part A\n* HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice\n* HHCs diagnosed with influenza by health care professional in the past 4 weeks","ALL","3 Weeks","11 Years",{"count":504,"type":505},1100,"ESTIMATED","INTERVENTIONAL",[508],"PHASE3","This study consists of two parts: Part A Surveillance and Part B Transmission.\n\nThe main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' \\\u003C12 years with influenza treated with baloxavir marboxil.\n\nPart B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.",[511],"Influenza","2026-04-27",{"date":514,"type":515},"2026-05-01","ACTUAL",{"date":517,"type":515},"2023-11-22",{"date":519,"type":505},"2027-06-30",{"name":5,"class":6},51]