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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Mélanie BEGUINET contact

+333 83 15 34 79

M.BEGUINET@chru-nancy.fr

Aurélie BOCQUIER contact

+33372746292

Aurelie.bocquier@univ-lorraine.fr

France2 sites, 2 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

    Recruiting

Other trials in France

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.

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 groups in NCT07246382
Study groupRoleWhat they receive
Experimental groupExperimentalNursing homes in the experimental group will receive the ORANEAT antibiotic stewardship program.
Receives: Other: The ORANEAT program
Control groupNo interventionNursing 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted24 Nov 2025
  2. Study start14 Apr 2026
  3. Primary completion14 Jul 2027 (estimated)
  4. Study completion14 Jul 2028 (estimated)

Resources

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)
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 39807109

  • 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.

    PubMed 38448955

  • 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.

    PubMed 38141820

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.

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