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Antimicrobial ResistanceCEFECANCT02814877

Efficacy and Cost-effectiveness of Hospital Antimicrobial Stewardship Programs

An observational study of Antimicrobial Resistance, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of the project is to evaluate the efficiency and cost-effectiveness of different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first section of the project, the project team intend to map the different antimicrobial stewardship programs in French hospital, by… Read more about this study

Who is it for?
Any age
Conditions the study is for
Antimicrobial Resistance
What is being tested?
promotion of appropriate use of antibiotics in hospital
How many people
27 participants
Where
1 siteFrance
Study dates
1 Sep 2016to 31 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: healthcare facilities

Who may be able to join

  • French hospitals (acute care) selected

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site
  • Perozziello

    Paris

Other trials in France

About this study

The main objective of the project is to evaluate the efficiency and cost-effectiveness of different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first section of the project, the project team intend to map the different antimicrobial stewardship programs in French hospital, by investigating a sample of 30 healthcare facilities, and determine the strategies to be evaluated by the model. The investigators will also evaluate physicians' adherence to the intervention to promote better use of antibiotics and explore potential barriers and facilitators to the implementation of effective strategies.

Read the detailed description

Context: There is a steady increase of the incidence of multidrug resistant bacteria, including some which have become extremely resistant, causing infections that are more and more difficult to treat with antibiotics thus dramatically impairing patient prognosis.

Several guidelines prompt hospitals to set up antimicrobial stewardship programs, with an antibiotic referrer or a dedicated team as a key component. The aim of the study is to encourage a better use of antibiotics, and to contain the emergence of resistance.

However, such programs, when they exist, cover multiple organisations and interventions to improve antimicrobial prescribing, and involve actors from different specialties. Furthermore, there is little information on how antimicrobial stewardship programs are actually implemented in hospitals and the impact of these programs has been difficult to measure.

Many studies, mainly conducted in England and in the United States, have evaluated interventions to control antibiotic prescription in hospitals. Two meta-analyses conclude that they are efficient but the variety of the interventions and the heterogeneity of the obtained results prevent any conclusions on which practices and strategies should be prioritized when conducting antimicrobial control programs.

The studies conducted so far have been mostly monocentric and have evaluated the impact of the interventions on a relatively short period of time. Finally, they rarely considered the costs and the cost-effectiveness of these programs.

More qualitative approaches have highlighted contextual and cultural factors that influence antibiotic prescribing habits and encourage deliverers to consider these factors when designing an intervention to promote appropriate antibiotic use. These studies have also emphasized that prescribers' adherence to guidelines and interventions is a fundamental factor in the success of any strategy. These aspects have not been explored much in the French national context.

Objective: The main goal is to evaluate the efficacy and the cost-effectiveness of strategies to promote appropriate use of antibiotics in hospitals and to identify the most efficient ones, on a short-term but also long-term scale.

The secondary objectives are 1) to map the different antimicrobial stewardship setups in French hospitals and determine the strategies to be evaluated by the model; 2) to measure prescribers' adherence to the different strategies used to control antibiotic prescription, and 3) to identify potential barriers and facilitators to the implementation of effective stewardship programs.

Methods: The project team will use modelling methods and techniques which combine a decision tree and a Markov model to estimate the impact of the different strategies, while considering the associated costs. To define the different strategies (restrictive, educational or structural strategies) and to measure clinicians' adherence to the strategy implemented in their setting, the project team will conduct a survey in a sample of 30 French hospitals (acute care). During this section, the project team will also collect a certain amount of quantitative data (antibiotic consumption per molecule, mean treatment length for selected infections…). These data will help us refine the model's parameters. To supply the model, other resources will be used : data from the relevant literature, computerized system of medical databases Outcome measurements: Main objective: A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact; secondary objectives: accrue high-value information in the field of antibiotic stewardship, namely physicians' adherence to antibiotic counselling and interventions to control its use, as well as potential barriers and facilitators for the effective implementation of such programs.

Study population: Our study is based on modelling patients' hospitalisations and hospitalisation returns on a hypothetical cohort of patients, over a 10 year period.

Being tested
promotion of appropriate use of antibiotics in hospital
Keywords
Antibiotic stewardship, cost-effectiveness evaluation, Antibiotic use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • promotion of appropriate use of antibiotics in hospitalOther

    promotion of appropriate use of antibiotics in hospital by visiting physicians

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy and the cost-effectiveness of strategies to promote appropriate use of antibiotics in hospitals and identify the most efficient ones, on a short-term but also long-term scale.

    A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact

    Measured: 12 months

Secondary outcomes (3)
  1. to map the different antimicrobial stewardship setups in french hospital

    accrue high-value information in the field of antibiotic stewardship,

    Measured: 12 months

  2. to measure prescribers' adherence to the different strategies used to control antibiotic description

    namely physicians' adherence to antibiotic counselling and interventions to control its use for the effective implementation of such programs.

    Measured: 12 months

  3. to identify potential barriers and facilitators to the implementation of effective stewardship programs

    namely physicians' adherence to antibiotic counselling and potential barriers and facilitators for the effective implementation of such programs.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2016 (estimated)
  2. Study start1 Sep 2016
  3. Primary completion1 Sep 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02814877
Sponsor's protocol ID
PHRQ15622
Acronym
CEFECA
Status last verified
Oct 2025
First submitted
16 Jun 2016
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Perozziello A, Routelous C, Charani E, Truel A, Birgand G, Yazdanpanah Y, Lescure FX, Lucet JC; CEFECA Study Group. Experiences and perspectives of implementing antimicrobial stewardship in five French hospitals: a qualitative study. Int J Antimicrob Agents. 2018 Jun;51(6):829-835. doi: 10.1016/j.ijantimicag.2018.01.002. Epub 2018 Jan 12.

    PubMed 29339297
  • Perozziello A, Lescure FX, Truel A, Routelous C, Vaillant L, Yazdanpanah Y, Lucet JC; CEFECA study group. Prescribers' experience and opinions on antimicrobial stewardship programmes in hospitals: a French nationwide survey. J Antimicrob Chemother. 2019 Aug 1;74(8):2451-2458. doi: 10.1093/jac/dkz179.

    PubMed 31167027

Questions about this trial

What is this clinical trial studying?

An observational study of Antimicrobial Resistance, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy and the cost-effectiveness of strategies to promote appropriate use of antibiotics in hospitals and identify the most efficient ones, on a short-term but also long-term scale. (time frame: 12 months). 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 NCT02814877, which also lists 2 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 24 Nov 2025.

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