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AzTrials

Antibiotic ResistanceACTIONNCT04028830

Impact on Antibiotic Prescriptions of a Bundle Intervention Conducted by Medical Representatives in General Practitioner Facilities, Based on Operational Demonstration of an Internet Decision Support Tool: Antibioclic

A study testing Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC and Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support in people with Antibiotic Resistance, run by Nantes University Hospital 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

At the international level, several experiments have been conducted to modify antibiotic prescribing practices in GPs. The mere development of training or the mere provision of information on the internet do not seem to change the practices when these interventions are conducted in isolation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Antibiotic Resistance
What is being tested?
Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC and Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,501 participants
Where
1 siteFrance
Study dates
15 Jul 2019to 15 Jan 2021
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • GPs practicing on one of the 5 departments of the study having seen at least 100 different patients (whatever the age) during the year preceding the evaluation.

Who cannot join

  • Will not be included attending GPs
  • who will be identified as having a particular exercise. And / or
  • that will already be integrated into an antibiotic prevention program

Trial locations and contacts

1 site in 1 country.

France1 site
  • University Hospital

    Nantes, 44000

Other trials in France

About this study

At the international level, several experiments have been conducted to modify antibiotic prescribing practices in GPs. The mere development of training or the mere provision of information on the internet do not seem to change the practices when these interventions are conducted in isolation. On the other hand, various approaches involving communication training, specific educational interventions working on ideas received from examples, interventions at the point of care, and the use of electronic decision support systems have demonstrated beneficial effects on prescription. The fact of sending feedback on their prescribing practices back to GPs also showed an impact

The Antibioclic website was created in 2011. It is an internet tool for prescribing help developed for general practitioners. Every day, it is consulted on average by 9000 health professionals. One question is how far the use of the site makes it possible to modify prescribing practices, which would justify, if need be, to actively promote it to general practitioners who do not use it. (The council of the order of doctors counted a little more than 88000 general practitioners in 2018.)

Read more

One challenge would be to implement a strategy:

  • combining different actions that have shown their impact: visit to the place of care, awareness of antibiotic resistance, work on preconceived ideas, feedback on practices, use of decision support tools,
  • and generalizable nationally.

The proposed study will thus experiment with an intervention modality based on the visit of a medical representative in general practitioner facilities, with:

  • antibiotic resistance sensitization,
  • work on preconceived ideas,
  • feedback on prescriptions,
  • use of an Internet tool to assist in the prescription of antibiotics: Antibioclic.

The generalizability of the intervention will be based on the collaboration with the medical representatives , which already intervene in an operational and regular way on this topic on the whole France. The medical representatives, distributed throughout the country, provide regular visits to the GPs and promote good practices. This type of visit to GPs is original internationally, demonstrating its impact on practices is decisive.

The purpose of the research is to compare the effect on antibiotic prescriptions made by general practitioners after 12 months of follow-up, i) an intervention led by the medical representatives in general practitioner facilities, the intervention involving usual visit (antibiotic resistance sensitization, work on preconceived ideas, feedback on practices) and demonstration of the use of Antibioclic, ii) an intervention conducted on the same terms by the the medical representatives but without Antibioclic demonstration, iii) compared to usual practice.

Being tested
Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC, Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support

What participants receive

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

  • Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLICOther

    Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC

  • Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision supportOther

    Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support

Study groups in NCT04028830
Study groupRoleWhat they receive
Arm 1ExperimentalMedical representative presentation with the help internet tool for decision ANTIBIOCLIC
Receives: Other: Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC
Arm 2ExperimentalMedical representative presentation without presentation of the internet tool for decision support
Receives: Other: Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support
Arm 3No interventionUsual practice without intervention regarding the prescription of antibiotics

What is being measured

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

  1. The primary endpoint will be the overall volume of antibiotics delivered in Defined Daily Dose (DDD) per participating GP, after 12 months of follow-up.

    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 posted23 Jul 2019
  2. Study start15 Jul 2019
  3. Primary completion15 Jan 2021
  4. Study completion15 Jan 2021

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04028830
Sponsor's protocol ID
RC19_0459
Acronym
ACTION
Status last verified
Apr 2024
First submitted
19 Jul 2019
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jeanmougin P, Larramendy S, Fournier JP, Gaultier A, Rat C. Effect of a Feedback Visit and a Clinical Decision Support System Based on Antibiotic Prescription Audit in Primary Care: Multiarm Cluster-Randomized Controlled Trial. J Med Internet Res. 2024 Dec 18;26:e60535. doi: 10.2196/60535.

    PubMed 39693139

Questions about this trial

What is this clinical trial studying?

A study testing Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC and Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support in people with Antibiotic Resistance, run by Nantes University Hospital 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 3 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 14 Sep 2026. 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?

The primary endpoint will be the overall volume of antibiotics delivered in Defined Daily Dose (DDD) per participating GP, after 12 months of follow-up. (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 NCT04028830, which also lists 1 linked publication.

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 14 Sep 2026.

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