[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623498":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":27,"locations":12,"responsibleParty":34,"collaborators":12,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":12,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":12,"enrollmentInfo":47,"targetDuration":12,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":62,"whyStopped":12,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":12},{"fullName":5,"class":6},"Hospital Italiano de Buenos Aires","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-intervention period","NO_INTERVENTION","The baseline phase preceding the implementation of the rapid PCR-based algorithm. During this period, the institutional workflow for carbapenemase-producing Enterobacterales (CPE) surveillance and isolation reevaluation relied exclusively on culture-based methods. Patients evaluated for CPE carriage or decolonization were tested using CHROMagar™ KPC and phenotypic confirmation methods (including MALDI-TOF and NG-Test CARBA 5 when indicated). Discontinuation of isolation required either three negative cultures or two negative cultures plus one PCR performed at least three months after the last positive result. No modification of staffing, alert systems, or isolation criteria occurred during this period.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Post-intervention period","ACTIVE_COMPARATOR","The implementation phase beginning November 6, 2024, when the rapid PCR-based diagnostic algorithm for carbapenemase-producing Enterobacterales (CPE) was incorporated into the existing infection control workflow. Real-time PCR was performed using the BD MAX™ System to detect bla\\_KPC, bla\\_NDM, bla\\_VIM\u002FIMP, and bla\\_OXA-48-like genes directly from rectal swabs. The infection control team coordinated sample requests, result communication, and isolation\u002Fde-isolation actions. The new algorithm prioritized PCR testing for surveillance and discontinuation of isolation in patients not receiving antibiotics, replacing culture-based testing in those scenarios.",[18],"Diagnostic Test: Rapid PCR-based algorithm for CPE detection",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Rapid PCR-based algorithm for CPE detection","Implementation of a rapid real-time PCR-based diagnostic algorithm for the detection of carbapenemase-producing Enterobacterales (CPE) integrated into the institutional infection control workflow. The BD MAX™ System detects bla\\_KPC, bla\\_NDM, bla\\_VIM\u002FIMP, and bla\\_OXA-48-like genes from rectal swabs. The infection control team manages the process from sample request to result-based isolation decision. The intervention began on November 6, 2024, upon availability of PCR supplies and reagents.",[14],[26],"Rapid molecular diagnostic algorithm for CPE; BD MAX CPE PCR workflow",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Emilio Felipe Huaier Arriazu, MD","CONTACT","+549 011 49590200","8165 \u002F 9542","emilio.huaier@hospitalitaliano.org.ar",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","EMILIO FELIPE HUAIER ARRIAZU","Emilio Felipe Huaier Arriazu, MD. Principal Investigator, Infection Control Committee","100623498","impact-of-implementing-a-rapid-pcr-based-algorithm-for-carbapenemase-producing-enterobacterales-cpe-and-infection-control-bundle-in-a-tertiary-hospital-100623498",false,"NCT07397416","Impact of Implementing a Rapid PCR-based Algorithm for Carbapenemase-producing Enterobacterales (CPE) and Infection Control Bundle in a Tertiary Hospital","Intervention in the CPE Surveillance Algorithm and Isolation Re-evaluation With the Addition of PCR vs. Culture-based Protocol: Real-life Time Differences","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n* Patients screened for carbapenemase-producing Enterobacterales (CPE) carriage by perianal swab within the first 5 days of hospital admission\n* Patients newly identified as CPE-colonized, leading to initiation of contact isolation\n* Patients found to be decolonized, leading to discontinuation of contact isolation\n* Patients with indication for active surveillance at hospital admission:\n\n  * Transfer from another healthcare facility\n  * Hospitalization in another healthcare center within the previous month\n* Patients undergoing active surveillance during hospitalization:\n\n  * First surveillance swab in high-risk neutropenic patients (HAR flag)\n  * First surveillance swab in immunosuppressed units, such as hematopoietic stem-cell transplant wards\n* Patients evaluated for discontinuation of contact precautions who meet all of the following:\n\n  * Prior CPE-positive surveillance sample\n  * At least 3 months since the last positive result and last hospitalization\n  * No systemic antibiotic exposure during that period\n\nExclusion Criteria:\n\n* Lost samples\n* Insufficient samples\n* Invalid laboratory test results requiring repeat sampling","ALL","18 Years",{"count":48,"type":49},800,"ESTIMATED","INTERVENTIONAL",[52],"NA","Purpose:\n\nCarbapenemase-producing Enterobacterales (CPE) are a growing cause of healthcare-associated infections, linked to high morbidity, mortality, and cost. Current screening methods rely mainly on culture, which can take up to 48 hours and delay infection control actions.\n\nThis study aims to evaluate the real-life impact of implementing a rapid PCR-based algorithm for CPE detection compared with the standard culture-based protocol, focusing on time differences in isolation and de-isolation decisions in hospitalized patients.\n\nDesign:\n\nA quasi-experimental, before-and-after, retrospective study conducted at Hospital Italiano de Buenos Aires (HIBA).\n\nPrimary Outcome:\n\nTime (in hours) between rectal swab request and change in isolation status (application or removal of isolation label) before and after PCR implementation.\n\nPopulation:\n\nAdult patients (≥18 years) admitted between October 2023-April 2024 (pre-intervention) and October 2024-April 2025 (post-intervention), who had contact isolation initiated or discontinued based on CPE surveillance results.\n\nRationale:\n\nThe introduction of rapid molecular testing could reduce operational delays and unnecessary isolation days, optimizing resource use in a setting with high CPE endemicity.",[55],"Carbapenemase-Producing Enterobacterales (CPE) Colonization",[57,58,59,60,61],"Healthcare-Associated Infections","Antimicrobial Resistance","Enterobacteriaceae Infections","Nosocomial Colonization","Infection Control","NOT_YET_RECRUITING","2026-02-04",{"date":65,"type":66},"2026-02-09","ACTUAL",{"date":68,"type":49},"2026-03-01",{"date":70,"type":49},"2026-05-01",{"name":5,"class":6}]