NCT02816528

Brief Summary

France is a country strong consumer of antibiotics in Europe, specially in primary care. Outpatient antibiotic use represents around 90% of total antibiotic use and prescriptions come mainly from general practitioners. A literature review of antibiotic stewardship in primary care show that there is no evaluation of interest of giving information about consumption of antibiotics and bacterial resistance to general practitioners. The objective of this study is to demonstrate that practitioners implicated in the followed of consumption of antibiotics and bacterial resistance around their geographical area of practice could change and improve their practices in good use of antibiotics.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

3.9 years

First QC Date

June 10, 2016

Last Update Submit

May 3, 2019

Conditions

Chronic Disease

Keywords

AntibioticsPrimary careStewardshipGeneral practitioners

Outcome Measures

Primary Outcomes (1)

  • Consumption of antibiotics

    Antibiotics consumptions are provided by CNAMTS and calculated in defined daily dose DDD/1000 patient-days around the geographical area concerned by this study.

    36 months

Secondary Outcomes (1)

  • Bacterial resistance of Escherichia coli and Staphylococcus aureus

    36 months

Study Arms (2)

Training program

Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months.

Behavioral: Training program

Nothing

Not Trained Physicians

Interventions

Training programBEHAVIORAL

Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months.

Training program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General practitioners

You may qualify if:

  • General practitioners in a "Meurthe-et-Moselle" french department

You may not qualify if:

  • General practitioners out of "Meurthe-et-Moselle" french department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Béatrice DEMORE

    Centre Hospitalier Régional Universitaire, Brabois, Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 28, 2016

Study Start

June 24, 2016

Primary Completion

June 1, 2020

Study Completion

November 1, 2020

Last Updated

May 6, 2019

Record last verified: 2019-05