NCT04562571

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

July 6, 2020

Last Update Submit

September 18, 2020

Conditions

Antibiotic Prescription

Keywords

antibioticantibiotic stewardship

Outcome Measures

Primary Outcomes (1)

  • Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription

    prescription rate by all included GPs of all systemic antibiotics (J01 code according to the Anatomical Therapeutic Chemical - ATC - 2017 classification) between the "before" (2017-2018) and "after" (2018-2019) period using an auto regressive integrated moving average (ARIMA) model

    2 years

Secondary Outcomes (5)

  • Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions

    2 years

  • Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use

    2 years

  • Adherence of GPs regarding the intervention: display of the public commitment charter

    1 years

  • Adherence of GPs regarding the intervention: use patient information leaflets

    1 years

  • Acceptability of the intervention by GPs

    1 years

Study Arms (2)

Charter & patient information leaflets

EXPERIMENTAL

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

Other: Charter & patient information leaflets

Control

NO INTERVENTION

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

Interventions

Charter & patient information leafletsOTHER

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

Charter & patient information leaflets

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Lorraine

Nancy, Grand Est, 54000, France

Location

Related Publications (1)

  • 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.

    PMID: 35135624DERIVED

Study Officials

  • Céline Pulcini

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

September 24, 2020

Study Start

October 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 24, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)