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.
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.
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.
- Conditions
- Antimicrobial Resistance
- 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.
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)
to map the different antimicrobial stewardship setups in french hospital
accrue high-value information in the field of antibiotic stewardship,
Measured: 12 months
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
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.
- First posted28 Jun 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial ResistanceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christophe LUCET, Principal investigator, APHP
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 29339297Perozziello 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-effectiveness of Hospital Antimicrobial Stewardship Programs
- ClinicalTrials.gov ID
- NCT02814877
- Acronym / sponsor ID
- CEFECA / PHRQ15622
- Conditions
- Antimicrobial Resistance
- Keywords
- Antibiotic stewardship, cost-effectiveness evaluation, Antibiotic use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthcare facilities
Key inclusion criteria (1 listed)
- French hospitals (acute care) selected
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| promotion of appropriate use of antibiotics in hospitalpromotion of appropriate use of antibiotics in hospital by visiting physicians | Other | – |
Primary outcome
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
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
3 secondary outcomes
to map the different antimicrobial stewardship setups in french hospital
Time frame: 12 months
to measure prescribers' adherence to the different strategies used to control antibiotic description
Time frame: 12 months
to identify potential barriers and facilitators to the implementation of effective stewardship programs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 29339297Perozziello 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.
- Results publication: PubMed 31167027Perozziello 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean Christophe LUCET principal investigator
APHP
1 site in 1 country: see every site and its status.
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.