Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04820062
Other study ID # 20CH031
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2021
Est. completion date September 1, 2022

Study information

Verified date August 2021
Source Centre Hospitalier Universitaire de Saint Etienne
Contact GUILLAUME THIERY, MD PHD
Phone (0)4 77 12 78 53
Email guillaume.thiery@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Antibiotic resistance is a major threat in modern medicine. Overuse of antibiotics is an important driver of antibiotic resistance. In critical care setting, antibiotic therapies are widely used due to the high number of patients presenting with sepsis. 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 study is designed to investigate social, cultural, contextual and personal factors influencing antibiotic prescribing among French intensivists. The design will consist of three phases: - Phase 1: construction and validation of a questionnaire - Phase 2: the questionnaire will be sent to all intensivist, including residents, in France - Phase 3: qualitative study, based on semi-structured interviews. The current project represent phase 1 of the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 115
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Physicians with predominant intensive care practice - Resident, with a minimum of two-month experience in the intensive care unit Exclusion Criteria: - Refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Content Validity
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

Locations

Country Name City State
France Chu St Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Construct validity qualitative study, based on semi-structured interviews. months 18
Primary 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 Face validity the questionnaire will be sent to all intensivist, including residents, in France months 18
See also
  Status Clinical Trial Phase
Recruiting NCT04961580 - PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Completed NCT04187755 - Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever Phase 4
Active, not recruiting NCT05027893 - Complications After Lower Third Molar Surgery N/A
Completed NCT05260554 - Effect of Cranberry Extract on the Urinary System
Completed NCT03848104 - Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections
Completed NCT04196387 - Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study
Completed NCT04409769 - Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI