[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605796":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":10,"responsibleParty":23,"collaborators":10,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":30,"acronym":10,"eligibilityCriteria":31,"healthyVolunteers":28,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":42,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"Hospital Italiano de Buenos Aires","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Individuals with sepsis",null,"Individuals aged 18 years or older who present to the Adult Emergency Department (CEA) at the Hospital Italiano de Buenos Aires between 01\u002F01\u002F2017 and 10\u002F08\u002F2025 with sepsis or septic shock and requiring at least 48 hours of observation or admission. The COVID-19 pandemic period will be excluded.",[13],{"name":14,"affiliation":5,"role":15},"Emilio Felipe H Huaier Arriazu, MD","PRINCIPAL_INVESTIGATOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":21,"email":22},"Emilio Felipe Huaier Arriazu, MD","CONTACT","+5491149590200","8165 \u002F 9542","emilio.huaier@hospitalitaliano.org.ar",{"type":15,"investigatorFullName":24,"investigatorTitle":25,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"EMILIO FELIPE HUAIER ARRIAZU","Infectious disease physician, member of the Infectious disease department and the Infection control committee of Hospital Italiano de Buenos Aires","100605796","predictive-model-for-multidrug-resistance-in-patients-admitted-to-the-emergency-department-with-sepsis-100605796",false,"NCT07167173","Predictive Model for Multidrug Resistance in Patients Admitted to the Emergency Department With Sepsis","Inclusion Criteria\n\n* Adults aged 18 years or older.\n* Attended at the Adult Emergency Department of Hospital Italiano de Buenos Aires during the periods:\n\n  * January 1, 2017 - March 20, 2020, or\n  * May 1, 2022 - August 10, 2025.\n* Sepsis or septic shock at presentation and at least 48 hours of observation or hospital admission.\n* Bacterial cultures obtained during the initial evaluation.\n\nExclusion Criteria\n\n* No indication for antibiotic therapy within the first 48 hours of hospital admission.\n* No bacterial cultures performed within the first 48 hours of hospital admission.\n* SARS-CoV-2 infection diagnosed within the first 72 hours of hospital admission.","ALL","18 Years",{"count":35,"type":36},10000,"ESTIMATED","OBSERVATIONAL","Introduction: Timely and accurate antibiotic administration in emergency department (ED) patients with sepsis or septic shock is vital, given mortality rates of 20% and over 40%, respectively. In high antimicrobial resistance (AMR) settings, selecting effective empirical antibiotics is challenging, requiring a balance between efficacy and minimizing multidrug-resistant organism (MDRO) emergence. A predictive model estimating AMR probability could optimize antibiotic use, improve outcomes, and reduce resistance. Although risk factors are known, no single validated model exists for predicting multidrug resistance in sepsis. Accurate prediction must integrate patient history, pathogen profiles, infection source, and antibiotic characteristics.\n\nObjectives: To estimate AMR prevalence in adult ED patients with sepsis or septic shock and develop a validated predictive model estimating AMR probability and likely pathogens. The model will follow a three-phase approach: (1) predict culture positivity, (2) estimate pathogen likelihood, and (3) predict AMR. Additionally, we aim to describe individual-level statistics for both predictable and unpredictable cases based on model performance.\n\nMethods: A cross-sectional study will be conducted at Hospital Italiano's adult ED over 70 months (Jan 1, 2017-Mar 20, 2020 and May 1, 2022-Aug 10, 2025), excluding the COVID-19 period. Primary outcomes include culture positivity, bacterial species, and MDRO prevalence. Frequency analyses will use positive cultures, species, and resistance classifications (MDRO, MDR, XDR, PDR), including mechanisms (e.g., MRSA, ESBL, KPC, MBL, OXA). Denominators will include all sepsis patients and, separately, culture-positive cases. Confidence intervals (95%) will be calculated using normal approximation. Multivariate logistic regression with backward stepwise selection will identify predictors and interactions. A hierarchical model will be developed based on culture results, pathogen identification, and resistance profiles.",[40,41],"Sepsis","Septic Shock",[43,44,45],"Antimicrobial resistance","sepsis","predictive models","NOT_YET_RECRUITING","2025-09-03",{"date":49,"type":50},"2025-09-11","ACTUAL",{"date":52,"type":36},"2025-10-15",{"date":54,"type":36},"2025-10-31",{"name":5,"class":6}]