[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520486":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Maimónides Biomedical Research Institute of Córdoba","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Letermovir (prospective cohort)","EXPERIMENTAL","2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months",[13],"Drug: Letermovir 240 mg Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Valganciclovir (retrospective cohort)","NO_INTERVENTION","Retrospective cohort, of patients treated with Valganciclovir during 12 months",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Letermovir 240 mg Oral Tablet","Treatment will commence as soon as subjects can receive oral medication, with a maximum timeframe of 28 days after transplantation. If patients cannot receive oral medication after transplantation, initial prophylaxis with ganciclovir per clinical practice will be allowed. Medication will be discontinued 12 months after treatment initiation.",[9],[26],{"name":27,"affiliation":28,"role":29},"Julián C De la Torre Cisneros, MD","Hospital Universitario Reina Sofia de Cordoba","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Jose C Garrido Gracia, Ph.D","CONTACT","+34677906567","josecarlos.garrido@imibic.org",[37],{"facility":38,"status":18,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Universitario Reina Sofia","Córdoba","14004","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-4.77275,37.89155,{"lat":47,"lon":46},[50,53],{"name":51,"role":33,"phone":18,"phoneExt":18,"email":52},"Aurora Paez Vega, Ph.D","aumapave@hotmail.com",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[57],{"name":58,"class":59},"MERCK SHARP & DOHME DE ESPAÑA S.A.","UNKNOWN","100520486","phase-2-efficacy-of-letermovir-in-preventing-cytomegalovirus-cmv-infection-in-lung-transplant-recipients-vs-valganciclovir-100520486",false,"NCT06057194","Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.","Prospective Study to Assess the Efficacy of Letermovir Prophylaxis in Preventing CMV Infection in Lung Transplant Recipients Compared to a Retrospective Cohort Treated With Standard Valganciclovir Prophylaxis for 12 Months (LETERCOR Study)","LETERCOR","Inclusion Criteria (prospective cohort):\n\n* Adults over 18 years old\n* Lung transplant recipients (D+\u002FR-) pre-transplant.\n* Having an undetectable CMV polymerase chain reaction assay (PCR) within the 96 hours prior to the start of letermovir prophylaxis.\n* Patients who have provided written informed consent.\n\nExclusion Criteria (prospective cohort):\n\n* HIV-infected patients.\n* Patients with multivisceral transplant.\n* Patients unable to comply with the follow-up protocol.\n* Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis.\n* Patients with concurrent renal and hepatic insufficiency.\n\nInclusion Criteria (retrospective cohort):\n\n* Adults over 18 years old. Lung transplant recipients (D+\u002FR-) pre-transplant.\n* Patients treated with Valganciclovir prophylaxis for 12 months.\n* Patients transplanted within 2 years prior to the start of the study.\n* Patients with a complete 13-month follow-up and comparable data to the prospective cohort to evaluate the study's primary variables.\n\nExclusion Criteria (retrospective cohort):\n\n* HIV-infected patients.\n* Patients with multivisceral transplant.","ALL","18 Years",{"count":71,"type":72},90,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+\u002FR-) compared to a historical cohort of lung transplant recipients (D+\u002FR-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease.\"",[78],"Infections, Cytomegalovirus",[80,81,82],"Lung transplant","CMV prophylaxis","Cytomegalovirus","NOT_YET_RECRUITING","2023-09-25",{"date":86,"type":87},"2023-09-28","ACTUAL",{"date":89,"type":72},"2023-10",{"date":91,"type":72},"2027-04",{"name":5,"class":6},1]