Antibiotic ReactionNCT04820062
Antibiotic Prescribing Behavior Among French Intensivist: Construction and Validation of a Questionnaire
An observational study of Antibiotic Reaction, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Reaction
- What is being tested?
- Content Validity
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Physicians with predominant intensive care practice
- Resident, with a minimum of two-month experience in the intensive care unit
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Antibiotic Reaction
- Being tested
- Content Validity
- Keywords
- Antibiotic prescribing, questionnaire, Antibiotic resistance, behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Content ValidityOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: months 18
Secondary outcomes (1)
Face validity
the questionnaire will be sent to all intensivist, including residents, in France
Measured: months 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study startAug 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ReactionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume THIERY, MD PHD, Principal investigator, CHU ST ETIENNE FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820062
- Sponsor's protocol ID
- 20CH031
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prescribing Behavior Among French Intensivist: Construction and Validation of a Questionnaire
- ClinicalTrials.gov ID
- NCT04820062
- Acronym / sponsor ID
- 20CH031
- Conditions
- Antibiotic Reaction
- Keywords
- Antibiotic prescribing, questionnaire, Antibiotic resistance, behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Physicians with predominant intensive care practice
- Resident, with a minimum of two-month experience in the intensive care unit
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Content ValidityFor 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 | Other | – |
Primary outcome
Content validity
Time frame: months 18
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.
1 secondary outcome
Face validity
Time frame: months 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume THIERY, MD PHD principal investigator
CHU ST ETIENNE FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Reaction, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GUILLAUME THIERY, MD PHD ((0)4 77 12 78 53 ext. +33, guillaume.thiery@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content validity (time frame: months 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.