Impact of a Communication Toolkit on Antibiotic Prescribed by General Practitioners: a Randomised Trial

NCT ID: NCT04562571

Last Updated: 2020-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Antimicrobial resistance is a major public health threat and the overuse of antibiotics contributes to its development.

In France, outpatient antibiotic use remains above the European average. Ninety percent of antibiotics are prescribed to outpatients and 70% of these are prescribed by general practitioners.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotic Prescription

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Charter & patient information leaflets

A public commitment charter promoting antibiotic stewardship, signed by the general practitioner (GP) and displayed in the practice waiting room; a non-prescription pad, to be distributed to patients when an antibiotic is not needed; and a patient information leaflet to be used when antibiotics were prescribed

Group Type EXPERIMENTAL

Charter & patient information leaflets

Intervention Type OTHER

Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription

Control

No intervention, eligible general practitioners randomised in the control group not informed of the intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Charter & patient information leaflets

Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* working in the Lorraine region in France
* prescribing more than 25 antibiotic items per 100 patients without a chronic illness, aged 16 to 65 years
* proportion of patients treated with critical antibiotics exceeding 27% (among patients treated with antibiotics)

Exclusion Criteria

* practicing exclusively alternative medicine, such as homeopathy or acupuncture
* GPs reaching the retirement age in the two years following the beginning of the intervention or who were not working two years before
* GPs who had already displayed a commitment charter promoting antibiotic stewardship in their practice
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lorraine

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Céline Pulcini

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Université de Lorraine

Nancy, Grand Est, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Essilini A, Le Dref G, Bocquier A, Kivits J, Welter A, Pulcini C, Thilly N; AntibioCharte scientific committee. French general practitioners' and patients' acceptability of a public commitment charter and patient information leaflets targeting unnecessary antibiotic use: a qualitative study. Antimicrob Resist Infect Control. 2022 Feb 8;11(1):32. doi: 10.1186/s13756-022-01065-3.

Reference Type DERIVED
PMID: 35135624 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201701939

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.