[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646861":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":49,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Hospital Italiano de Buenos Aires","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"CPE-Colonized ICU Patients",null,"Patients admitted to the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales (CPE). Participants will undergo quantitative culture and real-time PCR testing of rectal swabs as part of routine surveillance. Environmental samples will be collected from high-touch surfaces surrounding colonized patients to evaluate environmental contamination and transmission dynamics.",[13],{"name":14,"affiliation":5,"role":15},"Maria Ines Staneloni, MD","PRINCIPAL_INVESTIGATOR",[17,22],{"name":14,"role":18,"phone":19,"phoneExt":20,"email":21},"CONTACT","+549 011 49590200","8165 \u002F 9542","maria.staneloni@hospitalitaliano.org.ar",{"name":23,"role":18,"phone":19,"phoneExt":24,"email":25},"Emilio Felipe Huaier Arriazu, MD","8206","emilio.huaier@hospitalitaliano.org.ar",[27],{"facility":5,"status":10,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Buenos Aires","Buenos Aires F.D.","1199","Argentina","AR",{"type":34,"coordinates":35},"Point",[36,37],-58.37723,-34.61315,{"lat":37,"lon":36},[40,42,46,47],{"name":23,"role":18,"phone":41,"phoneExt":20,"email":25},"+549 011-49590200",{"name":43,"role":18,"phone":44,"phoneExt":20,"email":45},"CCI Comité de Control de Infecciones, MD","+54911-49590200","comite.infecciones@hospitalitaliano.org.ar",{"name":14,"role":15,"phone":10,"phoneExt":10,"email":10},{"name":23,"role":48,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":15,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"MARIA INES STANELONI","Principal Investigator",[53],{"name":54,"class":55},"National Council of Scientific and Technical Research, Argentina","OTHER_GOV","100646861","correlation-between-carbapenemase-producing-enterobacterales-load-environmental-contamination-and-transmission-in-critical-care-units-100646861",false,"NCT07685132","Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units","CPE-Load ICU S","Inclusion Criteria\n\n* Age 18 years or older.\n* Hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period.\n* Positive surveillance rectal swab for carbapenemase-producing Enterobacterales.\n\nExclusion Criteria\n\n-Patients colonized or infected with carbapenemase-producing Enterobacterales who remained in the same room for less than 48 hours.","ALL","18 Years",{"count":66,"type":67},60,"ESTIMATED","OBSERVATIONAL","Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs). Some colonized individuals may carry a particularly high bacterial burden and contribute disproportionately to environmental contamination and transmission to other patients. Identifying these high-risk individuals could improve infection prevention and control strategies.\n\nThis prospective observational study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. Patients identified as colonized with CPE through routine surveillance will undergo quantitative culture and real-time polymerase chain reaction (PCR) testing of rectal swabs to measure bacterial load. Environmental samples will also be collected from high-touch surfaces surrounding colonized patients. In selected cases, molecular typing methods will be used to evaluate genetic relatedness between patient and environmental isolates and to investigate possible transmission events.\n\nThe primary objective is to determine the correlation between bacterial load measured by culture and the PCR cycle threshold (Ct) value. Secondary objectives include evaluating the association between bacterial load and environmental contamination, and assessing whether patients with higher bacterial loads are more likely to contribute to transmission within the ICU. Results may help identify patients with increased dissemination potential and support targeted infection prevention interventions.",[71,72,73],"Healthcare-Associated Infections (HAIs)","Carbapenem-Resistant Enterobacteriaceae Colonization","Antimicrobial Resistance (AMR)",[75,76,77,78,79,80,81,82,83,84,85,86,87],"Carbapenemase-Producing Enterobacterales","CPE","Colonization","Super-Spreader","Cycle Threshold","Ct Value","Real-Time PCR","Environmental Contamination","Nosocomial Transmission","Infection Prevention and Control","Intensive Care Unit","Multidrug Resistance","Antimicrobial Resistance","NOT_YET_RECRUITING","2026-06-29",{"date":91,"type":92},"2026-07-06","ACTUAL",{"date":94,"type":67},"2026-08-01",{"date":96,"type":67},"2027-01-15",{"name":5,"class":6},1]