Chronic DiseaseSICAR-AmbNCT02816528
Efficacy of Information System Regarding the Consumption of Antibiotics and Bacterial Resistance in Primary Care
An observational study of Chronic Disease, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Training program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2016to Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General practitioners
Who may be able to join
- General practitioners in a "Meurthe-et-Moselle" french department
Who cannot join
- General practitioners out of "Meurthe-et-Moselle" french department
About this study
Official title: Efficacy of Information System Regarding the Consumption of Antibiotics and Bacterial Resistance on the Use of Antibiotics in Primary Care
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.
- Conditions
- Chronic Disease
- Being tested
- Training program
- Keywords
- Antibiotics, Primary care, Stewardship, General practitioners
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programBehavioural
Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Training program | Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months. Receives: Behavioral: Training program | |
| Nothing | Not Trained Physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (1)
Bacterial resistance of Escherichia coli and Staphylococcus aureus
The number of intermediate and resistant strains of E.coli and S.aureus are provided by MedQual around the geographical area concerned by this study.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start24 Jun 2016
- Primary completionJun 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, CNAMTS, Caisse Nationale d'Assurance Maladie des Travailleurs salariés, France, MedQual, Nantes, France
- Responsible party
- Sponsor
- Investigators
- Béatrice DEMORE, Principal investigator, Centre Hospitalier Régional Universitaire, Brabois, Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816528
- Sponsor's protocol ID
- PREPS-15-000171
- Acronym
- SICAR-Amb
- Status last verified
- May 2019
- First submitted
- 10 Jun 2016
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Information System Regarding the Consumption of Antibiotics and Bacterial Resistance on the Use of Antibiotics in Primary Care
- ClinicalTrials.gov ID
- NCT02816528
- Acronym / sponsor ID
- SICAR-Amb / PREPS-15-000171
- Conditions
- Chronic Disease
- Keywords
- Antibiotics, Primary care, Stewardship, General practitioners
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, CNAMTS, Caisse Nationale d'Assurance Maladie des Travailleurs salariés, France, MedQual, Nantes, France
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training program | – | Behavioral: Training programPhysicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months. |
| Nothing | – | –Not Trained Physicians |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General practitioners
Key inclusion criteria (1 listed)
- General practitioners in a "Meurthe-et-Moselle" french department
Key exclusion criteria (1 listed)
- General practitioners out of "Meurthe-et-Moselle" french department
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 |
|---|---|---|
| Training programPhysicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months. | Behavioural | Training program |
Primary outcome
Consumption of antibiotics
Time frame: 36 months
Antibiotics consumptions are provided by CNAMTS and calculated in defined daily dose DDD/1000 patient-days around the geographical area concerned by this study.
1 secondary outcome
Bacterial resistance of Escherichia coli and Staphylococcus aureus
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Béatrice DEMORE principal investigator
Centre Hospitalier Régional Universitaire, Brabois, Pharmacy
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Central Hospital, Nancy, 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 1 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 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of antibiotics (time frame: 36 months). 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 6 May 2019.