[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646938":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":37,"locations":46,"responsibleParty":68,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Molecular Microbiology-Guided Stewardship","EXPERIMENTAL","Antimicrobial stewardship strategy in which multiplex molecular microbiology results are reviewed in real time and integrated with predefined clinical and laboratory criteria to guide antimicrobial optimization and stewardship recommendations.",[13],"Behavioral: Protocolized Antimicrobial Stewardship Strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Antimicrobial Stewardship","ACTIVE_COMPARATOR","Standard antimicrobial stewardship strategy based on routine clinical practice, using conventional clinical, laboratory, and microbiological information available to the stewardship team.",[19],"Behavioral: Standard Antimicrobial Stewardship",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Protocolized Antimicrobial Stewardship Strategy","A standardized antimicrobial stewardship strategy integrating multiplex molecular microbiology results with predefined clinical and laboratory criteria to support antimicrobial prescribing decisions.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Routine antimicrobial stewardship practice based on standard clinical assessment and conventional microbiological information.",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Mar Masiá Canuto, MD, PhD","Hospital General Universitario de Elche \u002F Universidad Miguel Hernández","STUDY_CHAIR",{"name":36,"affiliation":33,"role":34},"Félix Gutiérrez Rodero, MD, PhD",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"María Espinosa Pérez, MD","CONTACT","+34 675047622","espinosa_mariaper@gva.es",{"name":44,"role":40,"phone":26,"phoneExt":26,"email":45},"Sergio Padilla Urrea, MD, PhD","padilla_ser@gva.es",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hospital General Universitario de Elche","RECRUITING","Elche","Alicante","03203","Spain","ES",{"type":56,"coordinates":57},"Point",[58,59],-0.70107,38.26218,{"lat":59,"lon":58},[62,65],{"name":63,"role":40,"phone":64,"phoneExt":26,"email":42},"Maria Espinosa Pérez","(+34) 966 616 754",{"name":66,"role":40,"phone":26,"phoneExt":26,"email":67},"Leandro Lopez Gutiérrez","leandro.lopez@fisabio.es",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Maria Espinosa Perez","Clinical Investigator","100646938","molecular-microbiology--guided-antimicrobial-stewardship-versus-standard-stewardship-in-hospitalized-patients-100646938",false,"NCT07684300","Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients","Impact of Molecular Microbiology Integrated With Clinical Data on Antimicrobial Therapy Optimization: An Open-Label Cluster-Randomized Crossover Trial","PROACT","Inclusion Criteria:\n\n* Age ≥18 years\n* Hospitalized in one of the participating study units at Hospital General Universitario de Elche.\n* Initiation of empiric high-impact antimicrobial therapy subject to antimicrobial stewardship program (ASP) review.\n* Provision of written informed consent by the participant or, when applicable, by a legally authorized representative.\n\nExclusion Criteria:\n\n* Severe immunosuppression with profound neutropenia (\\\u003C100 neutrophils\u002Fmm³).\n* Previous enrollment in this clinical trial.\n* Expected survival of less than 48 hours.\n* Documented microbiological identification of the presumed causative pathogen by conventional methods in a representative and\u002For sterile sample before randomization and before availability of multiplex molecular microbiology results.","ALL","18 Years",{"count":83,"type":84},250,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to learn whether integrating rapid multiplex molecular microbiology results with predefined clinical and laboratory criteria into an antimicrobial stewardship program improves antimicrobial use in hospitalized adults receiving empiric high-impact antimicrobial therapy.\n\nThe main questions it aims to answer are:\n\nDoes this strategy reduce the duration of exposure to high-impact antimicrobial therapy compared with standard antimicrobial stewardship practice? Does this strategy improve the appropriateness of antimicrobial treatment? Does this strategy affect clinical outcomes, including hospital readmission, intensive care unit admission, infection recurrence, mortality, and healthcare costs? Researchers will compare a protocolized antimicrobial stewardship strategy that incorporates multiplex molecular microbiology results and predefined clinical criteria with the standard antimicrobial stewardship strategy currently used in the hospital.\n\nParticipants will:\n\nReceive antimicrobial management according to the stewardship strategy assigned to their hospital unit during the study period.\n\nUndergo molecular microbiology testing and routine clinical and laboratory assessments as part of standard hospital care when indicated.\n\nBe followed to evaluate antimicrobial exposure, treatment appropriateness, safety outcomes, hospital readmission, intensive care unit admission, infection recurrence, mortality, and healthcare costs.",[90,91,92,93],"Infection","Antimicrobial Stewardship Program","Antimicrobial Resistance","Multiplex PCR",[93,95,96,92,97,98,99,100,101],"Molecular Microbiology","Antimicrobial Stewardship","Antibiotic Optimization","Antimicrobial Therapy","infectious Diseases","Cluster Randomized Trial","Crossover Trial","2026-07-01",{"date":104,"type":105},"2026-07-06","ACTUAL",{"date":107,"type":105},"2026-04-10",{"date":109,"type":84},"2027-06",{"name":70,"class":6},1]