Evaluation of a Customizable Antibiotic Stewardship Program Tailored to French Nursing Homes

NCT07246382 | Not Yet Recruiting

• 3 other identifiers: ANR-20-PAMR-000821-8412021/170
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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). This 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/1000 resident-days/month.

Conditions

Antibacterial Agents

Keywords

Antimicrobial Stewardship; Nursing Homes

Outcome Measures

Primary Outcomes (2)

• Total antibiotic use (DDD)

  Total antibiotic use expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.

  12 months

• Total antibiotic use (Number of prescriptions)

  As part of a sensibility analysis: Total antibiotic use expressed in number of prescriptions/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.

  12 months

Secondary Outcomes (2)

• Safety of the intervention

  12 months

• Sustainability of the effectiveness

  24 months

Other Outcomes (13)

• Context of the intervention - Nursing homes' characteristics

  At inclusion

• Adoption of the intervention

  12 months

• Reach of the target population

  Through the end of the intervention, an average of 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Nursing homes in the experimental group will receive the ORANEAT antibiotic stewardship program.

Other: The ORANEAT program

Control group

NO INTERVENTION

Nursing homes in the control group will not receive the ORANEAT antibiotic stewardship program ("usual care").

Interventions

The ORANEAT program OTHER

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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/or in infection prevention and control who agreed to participate in the study)

You may not qualify if:

• Nursing home with a pharmacy for internal use
• Participation to the pilot study
• Data from the Health Insurance reimbursement database (Système national des données de santé) not available on the study period
• Refusal of the nursing director to participate in the study (for Arm 1 only)
• Residents (Outcomes 1 to 4 and outcome 12)
• Resident aged 18 or more who had lived in one of the participating nursing homes during the study period.
• Healthcare professionals (Outcomes 11, 13 and 15)
• 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).
• Refusal to complete the self-administered questionnaires or to participate in qualitative investigations.

Sponsors & Collaborators

• University of Lorraine: lead
• Sciences Po, Centre de Sociologie des Organisations (CSO), CNRS, Paris, France.: collaborator
• Inserm U1219, Bordeaux Population Health Research Center, Bordeaux, France.: collaborator
• Centre Régional en Antibiothérapie (CRAtb) Grand Est, Nancy, France.: collaborator
• Centre Régional en Antibiothérapie (CRAtb) Pays de la Loire, Nantes, France.: collaborator
• National Research Agency, France: collaborator
• Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Pays de la Loire, Nantes, France.: collaborator
• Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Grand Est, Nancy, France.: collaborator

Related Publications (3)

• Gonthier D, Ricci L, Buzzi M, Birgand G, Kivits J, Agrinier N. Exploration of interprofessional collaboration for the diagnosis of infections and antibiotic prescription in nursing homes using multiple case study observational research. JAC Antimicrob Resist. 2025 Jan 13;7(1):dlae205. doi: 10.1093/jacamr/dlae205. eCollection 2025 Feb.

  PMID: 39807109 RESULT

• Bocquier A, Erkilic B, Babinet M, Pulcini C, Agrinier N; ORANEAT Study Group. Resident-, prescriber-, and facility-level factors associated with antibiotic use in long-term care facilities: a systematic review of quantitative studies. Antimicrob Resist Infect Control. 2024 Mar 6;13(1):29. doi: 10.1186/s13756-024-01385-6.

  PMID: 38448955 RESULT

• Conlin M, Hamard M, Agrinier N, Birgand G; ORANEAT co-investigators. Assessment of implementation strategies adopted for antimicrobial stewardship interventions in long-term care facilities: a systematic review. Clin Microbiol Infect. 2024 Apr;30(4):431-444. doi: 10.1016/j.cmi.2023.12.020. Epub 2023 Dec 22.

  PMID: 38141820 RESULT

Study Officials

• 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

Central Study Contacts

Amandine OSTERMANN

CONTACT

0383153530; a.ostermann@chru-nancy.fr

Aurélie BOCQUIER

CONTACT

0372746292; Aurelie.bocquier@univ-lorraine.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statisticians responsible for analyzing data on antibiotic use (using data from the Health Insurance reimbursement database, Système national des données de santé)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomized controlled trial with two parallel arms (ORANEAT program vs. no specific intervention); the cluster being the nursing home.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: November 24, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share