[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626167":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":61,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":18,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":18,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":98,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Federal University of Health Science of Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Biofire FilmArray group","EXPERIMENTAL","Patients with clinical suspicion of CNS infection and pleocytosis (CSF ≥ 5 cells\u002Fmm³) who will be prospectively tested using the BioFire FilmArray Meningitis\u002FEncephalitis panel",[13],"Diagnostic Test: Biofire FilmArray Meningitis\u002FEncephalitis Panel",{"label":15,"type":16,"description":17,"interventionNames":18},"Retrospective Control Group","NO_INTERVENTION","A retrospective cohort of patients from the last four years who presented with similar clinical syndromes and CSF pleocytosis (≥ 5 cells\u002Fmm³) but were managed with standard care without molecular panel testing.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","Biofire FilmArray Meningitis\u002FEncephalitis Panel","The Biofire FilmArray is a multiplex molecular diagnostic test that will be performed on 0.2 mL of cerebrospinal fluid (CSF) collected from patients via lumbar or suboccipital puncture. The system automatically performs DNA\u002FRNA extraction, purification, multiplex PCR, and identification of 14 different pathogens (6 bacteria, 7 viruses, and 1 fungus). The complete process takes approximately one hour and provides qualitative results to guide therapeutic decisions such as antibiotic stewardship.",[9],[26],{"name":27,"affiliation":28,"role":29},"Alessandro C Pasqualotto, PhD","Federal University of Health Sciences of Porto Alegre","STUDY_CHAIR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","+55 51 999951614","pasqualotto@ufcspa.edu.br",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Cândida Driemeyer, MD","+5551998793442","driemeyer@ufcspa.edu.br",[40],{"facility":41,"status":18,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Irmandande Santa Casa de Porto Alegre","Porto Alegre","Rio Grande do Sul","90020-090","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-51.23019,-30.03283,{"lat":51,"lon":50},[54,55,57,59],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},{"name":56,"role":32,"phone":37,"phoneExt":18,"email":38},"Candida Driemeyer, MD",{"name":27,"role":58,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":60,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":58,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Alessandro Pasqualotto","Head of the infectious diseases department and the molecular biology laboratory",[65,67],{"name":66,"class":6},"Irmandade Santa Casa de Misericórdia de Porto Alegre",{"name":68,"class":69},"BioMérieux","INDUSTRY","100626167","prediction-of-infectious-agents-in-the-biofire-filmarray-biomrieux-meningitisencephalitis-panel-based-on-clinical-syndrome-and-cerebrospinal-fluid-parameters-a-diagnostic-stewardship-proposal-100626167",false,"NCT07432113","Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis\u002FEncephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.","Inclusion Criteria:\n\nPatients aged 18 years or older, of any gender.\n\nPresence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.\n\nSymptoms must have started within the last 30 days.\n\nObligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells\u002Fmm³).\n\nProvision of written Informed Consent (TCLE) by the patient or their legal representative.\n\nExclusion Criteria:\n\n* Failure to sign the Informed Consent Form.\n\nClinical manifestations lasting more than 30 days.\n\nPatients under 18 years of age.\n\nPatients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).","ALL","18 Years",{"count":79,"type":80},182,"ESTIMATED","INTERVENTIONAL",[83],"NA","Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.\n\nObjective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis\u002FEncephalitis panel in patients with clinical syndrome of meningitis and\u002For encephalitis and pleocytosis (CSF ≥ 5 cells).\n\nAs secondary objectives, the study aims to:\n\nDetermine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.\n\nCompare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.\n\nCompare the time for identification of the causative pathogen and mortality rates between the study groups.\n\nPerform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.\n\nMethods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.",[86,87,88,89,90,91],"Meningitis","Encephalitic Infection","Encephalitis","Meningitis, Fungal","Meningitis, Viral","Meningitis, Bacterial",[93,94,95,96,97],"filmarray","biofire","biofire filmarray","meningits","encephalitis","NOT_YET_RECRUITING","2026-02-18",{"date":101,"type":102},"2026-02-25","ACTUAL",{"date":104,"type":80},"2026-03-16",{"date":106,"type":80},"2029-10-31",{"name":5,"class":6},1]