Antibacterial AgentsORANEATNCT07246382
Evaluation of a Customizable Antibiotic Stewardship Program Tailored to French Nursing Homes
A study testing The ORANEAT program in people with Antibacterial Agents, run by University of Lorraine at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibacterial Agents
- What is being tested?
- The ORANEAT program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Apr 2026to 14 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Resident aged 18 or more who had lived in one of the participating nursing homes during the study period.
- 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).
Who cannot join
- 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)
- /
- Healthcare professionals (Outcomes 11, 13 and 15)
- Refusal to complete the self-administered questionnaires or to participate in qualitative investigations.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CPias PdL (for the Pays de la Loire region)
Nantes, 44093
Gabriel BIRGAND, +332 40 08 39 86, gabriel.birgand@chu-nantes.fr
- Recruiting
CIC-EC (for the Grand Est region)
Vandœuvre-lès-Nancy, 54505
Nelly AGRINIER, +333 83 15 34 79, nelly.agrinier@univ-lorraine.fr
About this study
Official title: 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
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
- Being tested
- The ORANEAT program
- Keywords
- Antimicrobial Stewardship, Nursing Homes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ORANEAT programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Nursing homes in the experimental group will receive the ORANEAT antibiotic stewardship program. Receives: Other: The ORANEAT program |
| Control group | No intervention | Nursing homes in the control group will not receive the ORANEAT antibiotic stewardship program ("usual care"). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall antibiotic prescription rate (DDD)
Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month.
Measured using data from the Health Insurance reimbursement database.
Measured: 12 months
Overall antibiotic prescription rate (number of prescriptions)
As part of a sensitivity analysis:
Overall antibiotic prescription rate expressed in number of prescriptions/1000 resident-days/month.
Measured using data from the Health Insurance reimbursement database.
Measured: 12 months
Secondary outcomes (4)
Effectiveness of the intervention - broad-spectrum antibiotics
Broad-spectrum antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Broad-spectrum antibiotics include quinolones and 3rd-generation cephalosporins. Measured using data from the Health Insurance reimbursement database.
Measured: 12 months
Effectiveness of the intervention - appropriateness of antibiotic prescriptions
Proxy indicators reflecting the appropriateness of antibiotic use in nursing homes (Asquier-Khati et al. 2023, doi:10.1093/jacamr/dlad037). These proxy indicators assess the appropriateness of prescriptions for urinary tract infections, seasonal variations in prescriptions, repeated prescriptions of fluoroquinolones, cephalosporins' route of administration, duration of treatment, rate of second-line antibiotics, and co-prescriptions with non-steroidal anti-inflammatory drugs.
Measured: 12 months
Safety of the intervention
Number of hospital admissions/1000 resident-days and number of deaths/1000 resident-days among nusing home residents.
Measured using data from the Health Insurance reimbursement database.
Measured: 12 months
Sustainability of the effectiveness
Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month.
As part of a sensitivity analysis: Overall antibiotic prescription rate expressed in number of prescriptions/1000 resident-days/month.
Measured using data from the Health Insurance reimbursement database.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start14 Apr 2026
- Primary completion14 Jul 2027 (estimated)
- Study completion14 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antibacterial AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial with two parallel arms (ORANEAT program vs. no specific intervention); the cluster being the nursing home.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- Sciences Po, Centre de Sociologie des Organisations (CSO), CNRS, Paris, France., Inserm U1219, Bordeaux Population Health Research Center, Bordeaux, France., Centre Régional en Antibiothérapie (CRAtb) Grand Est, Nancy, France., Centre Régional en Antibiothérapie (CRAtb) Pays de la Loire, Nantes, France., National Research Agency, France, Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Pays de la Loire, Nantes, France., Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Grand Est, Nancy, France.
- Responsible party
- Principal investigator, Nelly Agriner, University of Lorraine
- Investigators
- Nelly AGRINIER, Professor, Principal investigator, Université de Lorraine, Inserm, INSPIIRE, F-54000 Nancy, France; CHRU-Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie clinique, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246382
- Sponsor's protocol ID
- ANR-20-PAMR-0008
- Other IDs
- 21-841, 2021/170
- Acronym
- ORANEAT
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD Sharing Plan Description: N/A
Publications
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.
PubMed 39807109Bocquier 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.
PubMed 38448955Conlin 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.
PubMed 38141820
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07246382
- Acronym / sponsor ID
- ORANEAT / ANR-20-PAMR-0008
- Conditions
- Antibacterial Agents
- Keywords
- Antimicrobial Stewardship, Nursing Homes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Collaborators
- Sciences Po, Centre de Sociologie des Organisations (CSO), CNRS, Paris, France., Inserm U1219, Bordeaux Population Health Research Center, Bordeaux, France., Centre Régional en Antibiothérapie (CRAtb) Grand Est, Nancy, France., Centre Régional en Antibiothérapie (CRAtb) Pays de la Loire, Nantes, France., National Research Agency, France, Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Pays de la Loire, Nantes, France., Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Grand Est, Nancy, France.
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 14 Jul 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial with two parallel arms (ORANEAT program vs. no specific intervention); the cluster being the nursing home.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: The ORANEAT programNursing homes in the experimental group will receive the ORANEAT antibiotic stewardship program. |
| Control group | No intervention | –Nursing homes in the control group will not receive the ORANEAT antibiotic stewardship program ("usual care"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- Resident aged 18 or more who had lived in one of the participating nursing homes during the study period.
- 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).
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ORANEAT programThe 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). | Other | Experimental group |
Primary outcome
Overall antibiotic prescription rate (DDD)
Time frame: 12 months
Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.
Overall antibiotic prescription rate (number of prescriptions)
Time frame: 12 months
As part of a sensitivity analysis: Overall antibiotic prescription rate expressed in number of prescriptions/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.
4 secondary outcomes
Effectiveness of the intervention - broad-spectrum antibiotics
Time frame: 12 months
Effectiveness of the intervention - appropriateness of antibiotic prescriptions
Time frame: 12 months
Safety of the intervention
Time frame: 12 months
Sustainability of the effectiveness
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 39807109Gonthier 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.
- Results publication: PubMed 38448955Bocquier 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.
- Results publication: PubMed 38141820Conlin 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.
- Individual participant dataSharing planned: No. IPD Sharing Plan Description: N/A
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nelly AGRINIER, Professor principal investigator
Université de Lorraine, Inserm, INSPIIRE, F-54000 Nancy, France; CHRU-Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie clinique, Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ORANEAT program in people with Antibacterial Agents, run by University of Lorraine at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie BEGUINET (+333 83 15 34 79, M.BEGUINET@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall antibiotic prescription rate (DDD) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246382, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.