[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653455":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":50,"armGroups":51,"interventions":45,"overallOfficials":45,"centralContacts":55,"locations":67,"responsibleParty":93,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":45,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":45,"enrollmentInfo":109,"targetDuration":45,"studyType":112,"phases":45,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":124,"whyStopped":45,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Hospital Italiano de Buenos Aires","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of refractory or resistant CMV infection","Proportion of solid organ transplant recipients with CMV infection who meet operational criteria for refractory infection (viral load unchanged or increased after 2 weeks of appropriate antiviral treatment) or resistant infection (refractory infection plus documented genetic mutation, e.g. UL97 and\u002For UL54, associated with antiviral resistance)","Within 18 months post-transplant, assessed retrospectively for the period January 2017 to December 2024",[14,18,21,25,29,33,37,41],{"measure":15,"description":16,"timeFrame":17},"Incidence of overall CMV infection","Proportion of SOT recipients with any CMV infection (primary infection, reactivation, asymptomatic infection, or disease), stratified by transplanted organ","Within 18 months post-transplant, 2017-2024",{"measure":19,"description":20,"timeFrame":17},"Distribution of clinical forms of CMV infection","Classification of CMV episodes as primary infection, reactivation, asymptomatic infection, or CMV disease",{"measure":22,"description":23,"timeFrame":24},"Frequency of antiviral resistance mutations","Proportion of genotyped refractory CMV episodes with ≥1 resistance-associated mutation (UL97 and\u002For UL54)","From T3 (declaration of refractoriness) to T4 (episode resolution), up to 12 months",{"measure":26,"description":27,"timeFrame":28},"Antiviral treatment lines and combination therapy use","Number of antiviral treatment lines used per episode (1, 2, ≥3) and proportion of episodes receiving combination antiviral therapy (≥2 active agents ≥72h)","From T2 (treatment initiation) to T4 (negativization) or last available PCR if not resolved, up to 12 months",{"measure":30,"description":31,"timeFrame":32},"All-cause mortality","Proportion of patients who died at 90 days and at 1 year after the CMV refractory\u002Fresistant episode","90 days and 1 year post-episode onset",{"measure":34,"description":35,"timeFrame":36},"Graft outcome","Proportion of patients with graft loss or rejection following the CMV refractory\u002Fresistant episode","rejection following the CMV refractory\u002Fresistant episode Through 1 year post-episode onset",{"measure":38,"description":39,"timeFrame":40},"Association between mutation type and antiviral treatment received","Distribution of antiviral treatment regimens received (ganciclovir, foscarnet, letermovir, maribavir, cidofovir, combination therapy) according to mutation type detected (UL97 vs. UL54 vs. none)","From T2 (antiviral treatment initiation) to T4 (episode resolution), up to 12 months",{"measure":42,"description":43,"timeFrame":44},"Virologic response","Time to virologic negativization (two consecutive negative PCR results ≥7 days apart)","From T2 (treatment initiation) to T4 (confirmed negativization), up to 12 months, with censoring at last available PCR for patients not achieving negativization",null,{"allocation":45,"interventionModel":45,"interventionModelDescription":45,"primaryPurpose":45,"observationalModel":47,"timePerspective":48,"maskingInfo":45},"COHORT","RETROSPECTIVE","Cytomegalovirus (CMV) remains one of the most frequent infections after solid organ transplantation (SOT), with important direct and indirect effects on graft and patient survival. While preventive strategies (prophylaxis and preemptive therapy) have reduced CMV-related disease and mortality, refractory and resistant CMV infection continues to be a major challenge, particularly in high-risk transplants (donor-positive\u002Frecipient-negative serostatus, and those receiving thymoglobulin induction). No epidemiological data on refractory or resistant CMV currently exist in Argentina.\n\nThis multicenter retrospective cohort study will include adult (≥18 years) solid organ transplant recipients from participating centers in Argentina who developed CMV infection within 18 months post-transplant, between January 1, 2017 and December 31, 2024. Cases meeting pre-specified operational criteria for refractory or resistant CMV infection will be identified from medical records. Refractory infection is defined as viral load that does not decrease or increases after two weeks of appropriate antiviral treatment; resistant infection is defined as refractory infection with documentation of at least one genetic mutation (UL97 and\u002For UL54) associated with antiviral resistance, confirmed through genotyping performed at the national reference laboratory (Instituto Malbrán).\n\nData will include demographic and transplant-related variables, immunosuppression regimen, virological monitoring, antiviral treatment lines and dosing, resistance genotyping results when available, and clinical outcomes including graft function, rejection episodes, and mortality at 90 days and one year. Data will be collected, coded, and stored in a centralized, de-identified database (REDCap) for descriptive and comparative statistical analysis.","Adult patients (≥18 years) who received a solid organ transplant (kidney, liver, heart, lung, pancreas, or combined transplant) at one of the participating centers in Argentina, and who developed cytomegalovirus (CMV) infection within 18 months following transplantation, during the period from January 1, 2017 to December 31, 2024. Cases are identified retrospectively from the transplant databases and medical records of each participating center.",[52],{"label":53,"type":45,"description":54,"interventionNames":45},"CMV-infected SOT recipients","Adult solid organ transplant recipients (kidney, liver, heart, lung, pancreas, or combined transplants) who developed CMV infection within 18 months post-transplant between 2017 and 2024, followed to identify episodes meeting criteria for refractory or resistant infection",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Laura Alicia Barcan, MD","CONTACT","+549 1149590200","8206","laura.barcan@hospitalitaliano.org.ar",{"name":63,"role":58,"phone":64,"phoneExt":65,"email":66},"Emilio Felipe Huaier Arriazu, MD","+549 011 49590200","8165 \u002F 9542","emilio.huaier@hospitalitaliano.org.ar",[68],{"facility":5,"status":45,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Buenos Aires","Buenos Aires F.D.","1199","Argentina","AR",{"type":75,"coordinates":76},"Point",[77,78],-58.37723,-34.61315,{"lat":78,"lon":77},[81,84,85,88,90,91],{"name":82,"role":58,"phone":83,"phoneExt":65,"email":66},"EMILIO Felipe HUAIER ARRIAZU, MD","+54911-49590200",{"name":57,"role":58,"phone":83,"phoneExt":60,"email":61},{"name":86,"role":87,"phone":45,"phoneExt":45,"email":45},"Astrid Smud, MD","SUB_INVESTIGATOR",{"name":57,"role":89,"phone":45,"phoneExt":45,"email":45},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":87,"phone":45,"phoneExt":45,"email":45},{"name":92,"role":87,"phone":45,"phoneExt":45,"email":45},"Natalia Pujato, MD",{"type":89,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"EMILIO FELIPE HUAIER ARRIAZU","Co investigator",[97],{"name":98,"class":99},"Takeda Pharmaceuticals North America, Inc.","INDUSTRY","100653455","cmv-refractory-and-resistant-infection-in-solid-organ-transplant-recipients-in-argentina-100653455",false,"NCT07787767","CMV Refractory and Resistant Infection in Solid Organ Transplant Recipients in Argentina","Evaluation of Cytomegalovirus Refractoriness and Resistance in Solid Organ Transplantation in Argentina: A Multicenter Study","Inclusion Criteria:\n\n* Adult patients (≥18 years) who received a solid organ transplant (kidney, liver, heart, lung, pancreas, or combined) at a participating center in Argentina between January 1, 2017 and December 31, 2024\n* Documented CMV infection within 18 months post-transplant\n* Followed for at least 18 months from transplant and at least 12 months from CMV infection onset\n\nExclusion Criteria:\n\n* Patients with incomplete medical records precluding assessment of CMV infection status or key study variables\n* Patients not meeting the minimum follow-up period from transplant or from infection onset","ALL","18 Years",{"count":110,"type":111},200,"ESTIMATED","OBSERVATIONAL","This study will describe the frequency and characteristics of refractory and resistant cytomegalovirus (CMV) infection in adults who received a solid organ transplant in Argentina between 2017 and 2024. Researchers will review medical records from transplant centers across the country to identify episodes of CMV infection that did not respond adequately to standard antiviral treatment (refractory) or that showed genetic mutations associated with drug resistance. The study will describe the clinical features, treatments used, and outcomes (including graft function and survival) of patients with these episodes, in order to better understand how common this problem is and what factors are associated with it in the local population.",[115,116,117],"Cytomegalovirus Infections","Solid Organ Transplantation Recipient","Solid Organ Transplantation",[119,120,121,122,123],"CMV","refractory infection","antiviral resistance","solid organ transplant","Drug Resistance, Viral","NOT_YET_RECRUITING","2026-08-22",{"date":127,"type":128},"2026-08-26","ACTUAL",{"date":130,"type":111},"2026-09-01",{"date":132,"type":111},"2027-03-01",{"name":5,"class":6},1]