[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542336":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Qantiferon CMV result communicated to the clinician in charge","EXPERIMENTAL","In this arm, the result of the CMV-QF will be communicated to the clinician in charge. If QF-CMV is positive, the clinician will be advised not to treat the patient. If QF-CMV is negative, he\u002Fshe will be advised to use or not antiviral therapy, according to the guidelines and the local practice.",[13,14],"Diagnostic Test: Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes).","Other: Communication of the result of the QF-CMV to the clinician in charge",{"label":16,"type":6,"description":17,"interventionNames":18},"Qantiferon CMV result NOT communicated to the clinician in charge","In this arm, the result of the CMV-QF will NOT be communicated to the clinician in charge. He\u002Fshe will be advised to use or not antiviral therapy, according to the guidelines and the local practice.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes).","The QF-CMV will be performed in all participants.",[16,9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Communication of the result of the QF-CMV to the clinician in charge","The result of the CMV-QF will be communicated to the clinician in charge only for the patients randomised in the group \"communication of the QF-CMV result to the clinician in charge\".",[9],[31],{"name":32,"affiliation":33,"role":34},"Martine Pernollet","CHU Grenoble Alpes","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Olivier Epaulard, MD, PhD","CONTACT","0476765291","oepaulard@chu-grenoble.fr",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Martine Pernollet, MD","0476766326","mpernollet@chu-grenoble.fr",[46],{"facility":33,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Grenoble","Maryland","38043","France","FR",{"type":54,"coordinates":55},"Point",[56,57],5.71479,45.17869,{"lat":57,"lon":56},[60,62],{"name":61,"role":38,"phone":39,"phoneExt":25,"email":40},"Olivier EPAULARD, MD, PHD",{"name":61,"role":38,"phone":25,"phoneExt":25,"email":25},{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100542336","quantiferon-cmv-to-identify-treatment-need-for-asymptomatic-cmv-infection-after-solid-organ-transplant-quantifot-100542336",false,"NCT06341543","Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)","Use of QuantiFERON® CMV in the Therapeutic Decision in Asymptomatic CMV Infection in Solid Organ Transplant Recipients","QUANTIFOT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Solid organ transplant recipient (heart, kidney, liver and lung)\n* Detectable CMV viral load between 1,000 and 15,000 IU\u002FmL (including 2 borderline values):\n\n  * Asymptomatic (no fever or organ dysfunction) ;\n  * Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;\n  * Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.\n* Having signed an informed consent form.\n* Affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Presence of anti-Herpesviridae treatment when CMV replication is detected (\\[val\\]aciclovir, \\[val\\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).\n* Pregnant or breast-feeding women.\n* Persons under guardianship or trusteeship.\n* Subjects under administrative or judicial supervision.\n* Subject unable to be contacted in case of emergency.","ALL","18 Years",{"count":76,"type":77},288,"ESTIMATED","INTERVENTIONAL",[80],"NA","Context\n\nCytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.\n\nMost of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and\u002For disease, and who ill benefit the most from antiviral therapy.\n\nAs CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).\n\nAim of the study\n\nThe aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.\n\nMethods\n\nParticipation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU\u002FmL.\n\nThe QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).\n\n* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.\n* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.\n\nIn the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).\n\nThe participants will be sampled:\n\n* 5 to 12 days after QF-CMV sampling (V2) ;\n* 7 to 14 days days after V2 (V3 - between D12 and D26) ;\n* 7 to 14 days days after V3 (V4 - between D19 and D40) .\n\nEndpoints\n\nThe primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:\n\n* Blood CMV viral load \\>10,000 IU\u002FmL \\[4 log\\];\n* And\u002For increase in blood viral load ≥0.5 log IU\u002FmL with CV otherwise \\>5000 IU\u002FmL;\n* And\u002For the onset of CMV disease.\n\nThe secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).",[83,84,85,86,87],"Cytomegalovirus Infections","Heart Transplantation","Kidney Transplantation","Lung Transplantation","Liver Transplantation",[89,90,91,92,93,94,95,96,97],"solid organ transplantation","cytomegalovirus","CMV","quantiferon","IGRA","interferon gamma release assay","antiviral","adverse effect","viremia","2024-09-27",{"date":100,"type":101},"2024-10-01","ACTUAL",{"date":103,"type":101},"2024-09-24",{"date":105,"type":77},"2026-10",{"name":5,"class":6},1]