CClinicalTrials.gg
CompletedNCT02814877CEFECAUpdated Nov 24, 2025

Efficacy and Cost-effectiveness of Hospital Antimicrobial Stewardship Programs

An observational study in Antimicrobial Resistance, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
27
Sex
All
01

Study 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 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.

02

Conditions studied

  • Antimicrobial Resistance

Keywords

  • Antibiotic stewardship
  • cost-effectiveness evaluation
  • Antibiotic use
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

healthcare facilities

Inclusion criteria

  • French hospitals (acute care) selected

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Interventions

  • Otherpromotion of appropriate use of antibiotics in hospital

    promotion of appropriate use of antibiotics in hospital by visiting physicians

06

What researchers measure

Primary outcomes

  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

    Time frame: 12 months

Secondary outcomes

  1. to map the different antimicrobial stewardship setups in french hospital

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 months

07

Study locations

1 site
  • Perozziello
    Paris, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02814877
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
Sep 1, 2016
Primary completion
Sep 1, 2017
Completion
Dec 31, 2017
Last update
Nov 24, 2025

Study contacts

Jean Christophe LUCET
principal investigator · APHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion