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Odpowiedzialno?Ci?","Wroclaw","53-149",{"type":42,"coordinates":446},[447,448],17.03006,51.10286,{"lat":448,"lon":447},{"facility":451,"status":35,"city":452,"state":30,"zip":453,"country":371,"countryCode":372,"cosmosGeoPoint":454,"geoPoint":458,"contacts":30},"NZOZ Salmed","Łęczna","21-010",{"type":42,"coordinates":455},[456,457],22.88135,51.30121,{"lat":457,"lon":456},{"facility":460,"status":78,"city":461,"state":462,"zip":463,"country":464,"countryCode":465,"cosmosGeoPoint":466,"geoPoint":470,"contacts":30},"Complejo Hospitalario Universitario de Santiago (CHUS)","Santiago de Compostela","LA Coruna","15706","Spain","ES",{"type":42,"coordinates":467},[468,469],-8.54569,42.88052,{"lat":469,"lon":468},{"facility":472,"status":78,"city":473,"state":30,"zip":474,"country":464,"countryCode":465,"cosmosGeoPoint":475,"geoPoint":479,"contacts":30},"Hospital Infantil Universitario Nino Jesus","Madrid","28009",{"type":42,"coordinates":476},[477,478],-3.70256,40.4165,{"lat":478,"lon":477},{"facility":481,"status":78,"city":473,"state":30,"zip":482,"country":464,"countryCode":465,"cosmosGeoPoint":483,"geoPoint":485,"contacts":30},"Hospital Universitario 12 de Octubre","28041",{"type":42,"coordinates":484},[477,478],{"lat":478,"lon":477},{"facility":487,"status":98,"city":488,"state":30,"zip":489,"country":464,"countryCode":465,"cosmosGeoPoint":490,"geoPoint":494,"contacts":30},"Hospital Universitari i Politècnic La Fe","Valencia","46026",{"type":42,"coordinates":491},[492,493],-0.37966,39.47391,{"lat":493,"lon":492},{"type":496,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100523309","phase-3-a-surveillance-study-of-susceptibility-to-baloxavir-marboxil-in-pediatric-participants-with-influenza-and-transmission-of-influenza-to-household-contacts-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":509,"type":510},1100,"ESTIMATED","INTERVENTIONAL",[513],"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.",[516],"Influenza","2026-04-27",{"date":519,"type":520},"2026-05-01","ACTUAL",{"date":522,"type":520},"2023-11-22",{"date":524,"type":510},"2027-06-30",{"name":5,"class":6},51]