Urinary Tract InfectionsABC-MGNCT06067386
Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
A study testing Dissemination of a selective reporting for antibiotic susceptibility testing and Standard antibiotic susceptibility testing report in people with Urinary Tract Infections, run by Nantes University Hospital at 1 site in France.
Trial summary
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Dissemination of a selective reporting for antibiotic susceptibility testing and Standard antibiotic susceptibility testing report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2023to 21 Nov 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients :
- women ≥18 years of age,
- affiliated with the CPAM of Loire Atlantique (44) or Maine et Loire (49),
- with a urine culture: i) analyzed by LabOuest, ii) positive for E. coli, and iii) associated with a prescription for antibiotics by a general practitioner in the period 7 days before and 14 days after the antibiotic susceptibility testing.
- General practitioners :
- practicing in primary care Loire Atlantique (44) and/or Maine et Loire (49),
- having been consulted by at least 100 different patients in the 12 months prior to baseline,
- having received at least one urine culture result for a woman ≥18 years of age analyzed by LabOuest over the 12 months prior to baseline.
Who cannot join
- Patients :
- hospitalized in the period 7 days before and 14 days after antibiotic susceptibility testing (data on antibiotics dispensed in healthcare institutions are not accessible via DCIR data),
- with reimbursements for antibiotics prescribed by physicians in different practices over the period 7 days before and 14 days after antibiotic susceptibility testing.
- General practitioners :
- with a special practice (acupuncture, allergology, angiology).
- not receiving any urine culture results analyzed by a laboratory of the LabOuest network in the year following the intervention
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Nantes, 44000
Jean-Pascal FOURNIER, Doctor, 02.40.41.28.28, jean-pascal.fournier@univ-nantes.fr
About this study
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics.
The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation).
The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.
- Conditions
- Urinary Tract Infections
- Being tested
- Dissemination of a selective reporting for antibiotic susceptibility testing, Standard antibiotic susceptibility testing report
- Keywords
- Antibiotic therapy, General practice, Primary care, Public health
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissemination of a selective reporting for antibiotic susceptibility testingOther
For each E. coli positive urine culture analyzed by LabOuest, GPs will receive an antibiotic susceptibility testing report, with the list of antibiotics restricted according to four E. coli susceptibility profiles, with an emphasis on narrower-spectrum antibiotics. The selected antibiotic susceptibility testing was developed following a targeted literature review and consultation with a steering committee including GPs, biologists and infectiologists. At the GP's request, a full antibiogram can be provided.
Standard antibiotic susceptibility testing reportOther
GPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | For each E. coli positive urine culture analyzed by LabOuest, GPs will receive an antibiotic susceptibility testing report, with the list of antibiotics restricted according to four E. coli susceptibility profiles, with an emphasis on narrower-spectrum antibiotics. The selected antibiotic susceptibility testing was developed following a targeted literature review and consultation with a steering committee including GPs, biologists and infectiologists. At the GP's request, a full antibiogram can be provided. Receives: Other: Dissemination of a selective reporting for antibiotic susceptibility testing |
| Control arm | Active comparator | GPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture. Receives: Other: Standard antibiotic susceptibility testing report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of broad-spectrum antibiotic dispensing
The primary endpoint will be the rate of broad-spectrum antibiotic dispensing, defined as the number of urine cultures associated with a prescription of broad-spectrum antibiotics (Amoxicillin/clavulanic acid, fluoroquinolone, third-generation cephalosporin) prescribed by GPs in the same practice over a period from 3 days before to 5 days after report of the antibiotic susceptibility testing, relative to the total number of urine cultures. This period of interest corresponds to the period of empirical antibiotic therapy (=within 3 days before report of the antibiotic susceptibility testing), and the period of directed antibiotic therapy (=within 5 days after report of the antibiotic susceptibility testing).
A sensitivity analysis of the primary endpoint will be carried out by varying the time window for broad-spectrum antibiotic dispensing around the date of the antibiotic susceptibility testing result, up to a maximum of 7 days before and 14 days after.
Measured: 5 days
Secondary outcomes (6)
Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)
This analysis will be restricted to women who have received no empirical antibiotic therapy (=within 3 days before report of the antibiotic susceptibility testing)
Measured: 5 days
"Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy
Measured: 5 days
Rate of broad-spectrum antibiotic dispensing as a function of the number of selective antibiotic susceptibility testings received per practice, as a continuous variable ("dose-effect") and ordinal variable ("threshold-effect")
Measured: 5 days
GP characteristics: demographics (age, gender), practice patterns (type of practice commune based on INSEE urban area zoning), number of encounters/year, and number of patients declared
Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test as a function of GP characteristics
Measured: 5 days
Patient characteristics (age, diabetes, pregnancy, nursing home)
Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test according to patient characteristics,
Measured: 5 days
E.coli antimicrobial susceptibility profiles
Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test based on E. coli antimicrobial susceptibility profiles
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start21 Nov 2023
- Primary completion21 Nov 2024 (estimated)
- Study completion21 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067386
- Sponsor's protocol ID
- RC22_0003
- Acronym
- ABC-MG
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
- ClinicalTrials.gov ID
- NCT06067386
- Acronym / sponsor ID
- ABC-MG / RC22_0003
- Conditions
- Urinary Tract Infections
- Keywords
- Antibiotic therapy, General practice, Primary care, Public health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 21 Nov 2024 (estimated)
- Study completion
- 21 Nov 2024 (estimated)
- First posted
- 4 Oct 2023 (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.
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics.
The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation).
The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Dissemination of a selective reporting for antibiotic susceptibility testingFor each E. coli positive urine culture analyzed by LabOuest, GPs will receive an antibiotic susceptibility testing report, with the list of antibiotics restricted according to four E. coli susceptibility profiles, with an emphasis on narrower-spectrum antibiotics. The selected antibiotic susceptibility testing was developed following a targeted literature review and consultation with a steering committee including GPs, biologists and infectiologists. At the GP's request, a full antibiogram can be provided. |
| Control arm | Active comparator | Other: Standard antibiotic susceptibility testing reportGPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- women ≥18 years of age,
- affiliated with the CPAM of Loire Atlantique (44) or Maine et Loire (49),
- with a urine culture: i) analyzed by LabOuest, ii) positive for E. coli, and iii) associated with a prescription for antibiotics by a general practitioner in the period 7 days before and 14 days after the antibiotic susceptibility testing.
- practicing in primary care Loire Atlantique (44) and/or Maine et Loire (49),
- having been consulted by at least 100 different patients in the 12 months prior to baseline,
Key exclusion criteria (6 listed)
- hospitalized in the period 7 days before and 14 days after antibiotic susceptibility testing (data on antibiotics dispensed in healthcare institutions are not accessible via DCIR data),
- with reimbursements for antibiotics prescribed by physicians in different practices over the period 7 days before and 14 days after antibiotic susceptibility testing.
- with a special practice (acupuncture, allergology, angiology).
- not receiving any urine culture results analyzed by a laboratory of the LabOuest network in the year following the intervention
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 |
|---|---|---|
| Dissemination of a selective reporting for antibiotic susceptibility testingFor each E. coli positive urine culture analyzed by LabOuest, GPs will receive an antibiotic susceptibility testing report, with the list of antibiotics restricted according to four E. coli susceptibility profiles, with an emphasis on narrower-spectrum antibiotics. The selected antibiotic susceptibility testing was developed following a targeted literature review and consultation with a steering committee including GPs, biologists and infectiologists. At the GP's request, a full antibiogram can be provided. | Other | Intervention arm |
| Standard antibiotic susceptibility testing reportGPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture. | Other | Control arm |
Primary outcome
Rate of broad-spectrum antibiotic dispensing
Time frame: 5 days
The primary endpoint will be the rate of broad-spectrum antibiotic dispensing, defined as the number of urine cultures associated with a prescription of broad-spectrum antibiotics (Amoxicillin/clavulanic acid, fluoroquinolone, third-generation cephalosporin) prescribed by GPs in the same practice over a period from 3 days before to 5 days after report of the antibiotic susceptibility testing, relative to the total number of urine cultures. This period of interest corresponds to the period of empirical antibiotic therapy (=within 3 days before report of the antibiotic susceptibility testing), and the period of directed antibiotic therapy (=within 5 days after report of the antibiotic susceptibility testing). A sensitivity analysis of the primary endpoint will be carried out by varying the time window for broad-spectrum antibiotic dispensing around the date of the antibiotic susceptibility testing result, up to a maximum of 7 days before and 14 days after.
6 secondary outcomes
Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)
Time frame: 5 days
"Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy
Time frame: 5 days
Rate of broad-spectrum antibiotic dispensing as a function of the number of selective antibiotic susceptibility testings received per practice, as a continuous variable ("dose-effect") and ordinal variable ("threshold-effect")
Time frame: 5 days
GP characteristics: demographics (age, gender), practice patterns (type of practice commune based on INSEE urban area zoning), number of encounters/year, and number of patients declared
Time frame: 5 days
Patient characteristics (age, diabetes, pregnancy, nursing home)
Time frame: 5 days
E.coli antimicrobial susceptibility profiles
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissemination of a selective reporting for antibiotic susceptibility testing and Standard antibiotic susceptibility testing report in people with Urinary Tract Infections, run by Nantes University Hospital 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 8 inclusion and 6 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 22 Apr 2024. 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 Jean-Pascal FOURNIER, Doctor (02.40.41.28.28, jean-pascal.fournier@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of broad-spectrum antibiotic dispensing (time frame: 5 days). 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 22 Apr 2024.