[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611884":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":18,"responsibleParty":39,"collaborators":42,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":18},{"fullName":5,"class":6},"University of Lorraine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Nursing homes in the experimental group will receive the ORANEAT antibiotic stewardship program.",[13],"Other: The ORANEAT program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Nursing homes in the control group will not receive the ORANEAT antibiotic stewardship program (\"usual care\").",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"The ORANEAT program","The ORANEAT multifaceted customizable antibiotic stewardship program includes (i) a contextual diagnostic regarding AMS in the targeted NH; (ii) based on the results of the contextual diagnostic, a bundle of tools selected from an AMS-toolkit including actions and tools suited to French NH setting and covering the main CDC domains of AMS in NHs; and (iii) implementation support relying on French structures involved in tackling AMR (i.e., CRAtb and CPias).",[9],[25],{"name":26,"affiliation":27,"role":28},"Nelly AGRINIER, Professor","Université de Lorraine, Inserm, INSPIIRE, F-54000 Nancy, France; CHRU-Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie clinique, Nancy, France","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Amandine OSTERMANN","CONTACT","0383153530","a.ostermann@chru-nancy.fr",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Aurélie BOCQUIER","0372746292","Aurelie.bocquier@univ-lorraine.fr",{"type":28,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Nelly Agriner","Professor",[43,46,48,50,52,54,56],{"name":44,"class":45},"Sciences Po, Centre de Sociologie des Organisations (CSO), CNRS, Paris, France.","UNKNOWN",{"name":47,"class":45},"Inserm U1219, Bordeaux Population Health Research Center, Bordeaux, France.",{"name":49,"class":45},"Centre Régional en Antibiothérapie (CRAtb) Grand Est, Nancy, France.",{"name":51,"class":45},"Centre Régional en Antibiothérapie (CRAtb) Pays de la Loire, Nantes, France.",{"name":53,"class":6},"National Research Agency, France",{"name":55,"class":45},"Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Pays de la Loire, Nantes, France.",{"name":57,"class":45},"Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Grand Est, Nancy, France.","100611884","evaluation-of-a-customizable-antibiotic-stewardship-program-tailored-to-french-nursing-homes-100611884",false,"NCT07246382","Evaluation of a Customizable Antibiotic Stewardship Program Tailored to French Nursing Homes","Evaluation of A Customizable Antibiotic Stewardship Program Based on a Comprehensive Assessment of Organizations and Health Professionals' Attitudes, and Tailored to French Nursing Homes' Needs","ORANEAT","Nursing homes\n\nInclusion criteria:\n\n• Nursing home located in one of the geographical areas participating in the study in two French regions (i.e., geographical areas covered by experts in antibiotic stewardship and\u002For in infection prevention and control who agreed to participate in the study)\n\nExclusion criteria:\n\n* Nursing home with a pharmacy for internal use\n* Participation to the pilot study\n* Data from the Health Insurance reimbursement database (Système national des données de santé) not available on the study period\n* Refusal of the nursing director to participate in the study (for Arm 1 only)\n\nResidents (Outcomes 1 to 4 and outcome 12)\n\nInclusion criteria:\n\n• Resident aged 18 or more who had lived in one of the participating nursing homes during the study period.\n\nExclusion criteria:\n\n\u002F\n\nHealthcare professionals (Outcomes 11, 13 and 15)\n\nInclusion criteria:\n\n• Healthcare professionals aged 18 or more working in one of the participating nursing homes from Arm 1 (including healthcare professionals who provide services to or collaborate with the nursing home even if they are not on-site, e.g., private general practitioners, community pharmacists, microbiologists, and professionals responsible for the implementation support).\n\nExclusion criteria:\n\n• Refusal to complete the self-administered questionnaires or to participate in qualitative investigations.",true,"ALL","18 Years",{"count":70,"type":71},66,"ESTIMATED","INTERVENTIONAL",[74],"NA","To tackle antimicrobial resistance (AMR), i.e., one of the top 10 global health threats, antimicrobial stewardship (AMS) programs, i.e., coherent sets of actions promoting responsible use of antimicrobials, have been developed. Despite growing evidence about their effectiveness, their implementation remains suboptimal. Qualifying as complex interventions, these programs are prone to interactions with context, potentially compromising their successful transfer to other settings. AMR remains critical in French nursing homes (NHs). AMS programs have proven effective in reducing antimicrobial resistance in hospitals and in NHs. However, the evidence is inconsistent across studies in NHs and mostly based on North American and North European AMS programs and studies, raising concerns about transferability that might occur while implementing such AMS programs in French NHs. For instance, health systems and NH funding and organization vary considerably across countries, resulting in potential key determinants driving antibiotic use in such facilities in some countries that might remain untargeted by AMS programs developed in other countries. In addition, inconsistent effectiveness of AMS programs in NHs might also result from implementation issues, raising concerns about the strategies used to implement such programs. Based on extensive logic models linking psychosocial and organizational determinants driving antibiotic use in NHs of diverse countries, we developed and pilot-tested a customizable AMS program (i.e., the ORANEAT program) suited to French NHs, including three major components: (i) a contextual diagnostic regarding AMS in the targeted NH; (ii) based on the results of the contextual diagnostic, a bundle of tools selected from an AMS-toolkit including actions and tools suited to French NH setting; and (iii) implementation support relying on French structures involved in tackling AMR (i.e., CRAtb and CPias).\n\nThis study aims to assess the effectiveness, the sustainability, the implementation, and the transferability of the ORANEAT program in French NHs, using a mixed-method approach (quantitative and qualitative data). A cluster randomized controlled trial with two arms (ORANEAT program vs. no specific intervention) will be conducted; the cluster being the NH. The primary outcome to measure the effectiveness is total antibiotic use expressed in defined daily doses\u002F1000 resident-days\u002Fmonth.",[77],"Antibacterial Agents",[79,80],"Antimicrobial Stewardship","Nursing Homes","NOT_YET_RECRUITING","2025-11-17",{"date":84,"type":85},"2025-11-24","ACTUAL",{"date":87,"type":71},"2025-12-15",{"date":89,"type":71},"2028-01-30",{"name":5,"class":6}]