[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lumos Diagnostics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100609241","febridx-pediatric-validation-study-100609241",false,"NCT07211997","FebriDx® Pediatric Validation Study","FebriDx® Pediatric Validation Study Protocol","Inclusion Criteria:\n\n* Signed informed consent by parent\u002Fguardian and Assent for ages 7-11 years\n* Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.4°F\u002F38°C within 3 days (72 hours) of enrollment\n* Clinical suspicion for Acute Respiratory Infection beginning within 7 days before enrollment AND presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath \u002F difficulty breathing\n\nExclusion Criteria:\n\n* Unwilling to participate in 7-day follow-up or sign HIPAA waiver to obtain medical record if hospitalized\n* Immunocompromised state or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral \u002F inhaled steroids, Methotrexate, Cyclosporine, Chemotherapy, interferon therapy)\n* Taking antibiotics or antiviral therapy in the last 14 days\n* Received a live viral immunization in the last 14 days\n* Clinical diagnosis of otitis media or recognizable viral syndrome (i.e., croup, varicella, stomatitis) at the time of enrollment\n* Prior enrollment in the study","ALL","2 Years","11 Years",{"count":20,"type":21},800,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.",[25],"Acute Respiratory Infections (ARIs)",[27,28,29,30,31,32],"Pediatric","Host immune response","Biomarkers","Point-of-Care","Myxovirus resistance protein A (MxA)","C-reactive protein (CRP)","RECRUITING","2025-10-30",{"date":36,"type":37},"2025-10-31","ACTUAL",{"date":39,"type":37},"2025-10-09",{"date":41,"type":21},"2026-11-30",{"name":43,"class":44},"Lumos Diagnostics","INDUSTRY",10,""]