[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584643":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":39,"overallOfficials":39,"centralContacts":48,"locations":54,"responsibleParty":74,"collaborators":39,"id":76,"slug":39,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":39,"enrollmentInfo":84,"targetDuration":39,"studyType":87,"phases":39,"briefSummary":88,"conditions":89,"keywords":39,"overallStatus":57,"whyStopped":39,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"IRCCS Sacro Cuore Don Calabria di Negrar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"Anti-OROV serum antibody response","Results of the anti-OROV serum antibody response along the study period:\n\n* IgM (titer, reciprocal of dilution);\n* IgG (titer, reciprocal of dilution).","Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO",{"measure":14,"description":15,"timeFrame":12},"OROV viral RNA shedding in different matrices","Results of OROV viral RNA presence in different matrice along the study period:\n\nRT-PCR Ct and RNA copies\u002FmL in different matrices: urine, whole blood, serum, vaginal swab or seminal fluid, CSF and amniotic fluid if available.",[17,21,24,27,30,33,36],{"measure":18,"description":19,"timeFrame":20},"Quality of anti-OROV humoral response","Results of the anti-OROV neutralizing antibody response along the study period:\n\nneutralizing antibodies titer (titer, reciprocal of dilution).","Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.",{"measure":22,"description":23,"timeFrame":12},"Quality of anti-OROV cell mediated immunity evolution","Results of the quality of anti-OROV cell mediatedimmune response along the study period: specific cell-mediated response (specific IFN producing cells\u002F100,000).",{"measure":25,"description":26,"timeFrame":20},"Quality of anti-OROV cytokine production","Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg\u002Fml)",{"measure":28,"description":29,"timeFrame":12},"Timing evolution of humoral OROV specific response","IgM and IgG kinetics (days from symptoms onset or first diagnosis).",{"measure":31,"description":32,"timeFrame":12},"Time duration limits of RT-PCR-positivity persistence in different matrices","RT-PCR positivity persistence (days from symptoms onset or first diagnosis)",{"measure":34,"description":35,"timeFrame":12},"Semi-quantitative OROV RNA viral loads evaluation","Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct)",{"measure":37,"description":38,"timeFrame":12},"Quantitative OROV RNA viral load evaluation","Results of OROV RNA copies along the study period: ddPCR (copies\u002FmL)",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":6,"maskingInfo":39},"COHORT","This is a study with retrospective and prospective enrollment.","The study population will consist of adult patients (age 18 years or over) with RT-PCR-confirmed OROV, who attended or will attend health services at the Center.",[45],{"label":46,"type":39,"description":47,"interventionNames":39},"OROV patients","The study population will consist of adult patients (age 18 years or over) with RT-PCR-confirmed OROV, who attended or will attend health services at DITM. During first clinical encounter, study participants will be interviewed and physically examined as part of routine clinical practice, in this occasion patients will be also approached to obtain informed consent by their attending physician; all the patients will also be asked the consent for the donation of residual samples from routine diagnostic tests to Tropica BioBank.\n\nRT-PCR and culture testing will be repeated at each clinical visit and will stop when one negative RT-PCR results from all matrices have been obtained. Immunologic testing will continue for the duration of the study.\n\nSubject participation duration will be about 3 months in total.",[49],{"name":50,"role":51,"phone":52,"phoneExt":39,"email":53},"Elvia Malo","CONTACT","+390456013111","ricerca.clinica@sacrocuore.it",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"IRCCS Sacro Cuore Don Calabria","RECRUITING","Negrar","VR","37024","Italy","IT",{"type":64,"coordinates":65},"Point",[66,67],10.93899,45.52918,{"lat":67,"lon":66},[70],{"name":71,"role":51,"phone":72,"phoneExt":39,"email":73},"Concetta Castilletti","+39(0)456013111","concetta.castilletti@sacrocuore.it",{"type":75,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100584643",false,"NCT06892015","OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS","OROVIMM","Inclusion Criteria:\n\n* patients resulted positive to the RT-PCR for OROV;\n* informed consent to the participation to the study and to personal data's treatment and\u002For donation of residual samples to Tropika Biobank;\n* patients ≥ 18 years old.\n\nExclusion Criteria\n\n• lack of signed informed consent.","ALL","18 Years",{"count":85,"type":86},30,"ESTIMATED","OBSERVATIONAL","This is a single-center observational study, whose primary objective is to describe the immune response to Oropouche Virus (OROV) during the study period and the duration of viral RNA shedding, only for sequential samples, by RT-PCR in different matrices.",[90],"Oropouche Infection","2025-05-16",{"date":93,"type":94},"2025-05-18","ACTUAL",{"date":96,"type":94},"2024-12-19",{"date":98,"type":86},"2026-10",{"name":5,"class":6},1]