NCT04820062

Brief Summary

Antibiotic resistance is a major threat in modern medicine. Overuse of antibiotics is an important driver of antibiotic resistance. However, some authors have shown that up to 50% of antibiotic treatments in critically ill patients are inappropriate, mostly because they are used in patients with non-bacterial infections. In order to improve antibiotic use, several antibiotic stewardship programs have been implemented worldwide. However, only few of them have taken into account the determinants of prescribing behaviors. Yet, these determinants have been shown to play a role among general practitioners of hospital doctors. Nevertheless, none of these factors have been studied among intensivists. The current project represent phase 1 of the study : construction and validation of a questionnaire.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

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

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

March 25, 2021

Last Update Submit

August 18, 2021

Conditions

Keywords

Antibiotic prescribingquestionnaireAntibiotic resistancebehavior

Outcome Measures

Primary Outcomes (1)

  • Content validity

    Construction and validation of a questionnaire by 2 experts in reanimation and infectiology. This questionnaire will include these items: demographic datas, medical data concerning the use of antibiotics, social data exploring the collective and social components of antibiotic prescription, personal data in search of individual factors, attitude to antibiotic therapy.

    months 18

Secondary Outcomes (1)

  • Face validity

    months 18

Other Outcomes (1)

  • Construct validity

    months 18

Interventions

For the validity of built, it is generally advisable to include a ratio of 100 participants for 30 questionnaire items. In order to have a suitable questionnaire, we will limit ourselves to 30 items which will be the size of our questionnaire. It was therefore planned to include 100 participants The selection of experts will be based on experience in this area, knowledge and availability. It will be a rescimant physician and an infectious disease doctor. Each expert will be invited in isolation to comment on the items in the questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physicians with predominant intensive care practice and Resident, with a minimum of two-month experience in the intensive care unit can be participe at this study.

You may qualify if:

  • Physicians with predominant intensive care practice
  • Resident, with a minimum of two-month experience in the intensive care unit

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu St Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Guillaume THIERY, MD PHD

    CHU ST ETIENNE FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

August 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations