Back to resultsSelective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs (ABC-MG)
Primary Purpose
Urinary Tract Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dissemination of a selective reporting for antibiotic susceptibility testing
Standard antibiotic susceptibility testing report
Sponsored by
About this trial
This is an interventional other trial for Urinary Tract Infections focused on measuring Antibiotic therapy, General practice, Primary care, Public health
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
Control arm
Arm Description
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.
GPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
"Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy
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")
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
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,
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
Full Information
NCT ID
NCT06067386
First Posted
September 22, 2023
Last Updated
September 28, 2023
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06067386
Brief Title
Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
Acronym
ABC-MG
Official Title
Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Antibiotic therapy, General practice, Primary care, Public health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
GPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture.
Intervention Type
Other
Intervention Name(s)
Dissemination of a selective reporting for antibiotic susceptibility testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard antibiotic susceptibility testing report
Intervention Description
GPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture.
Primary Outcome Measure Information:
Title
Rate of broad-spectrum antibiotic dispensing
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)
Description
This analysis will be restricted to women who have received no empirical antibiotic therapy (=within 3 days before report of the antibiotic susceptibility testing)
Time Frame
5 days
Title
"Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy
Time Frame
5 days
Title
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
Title
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
Description
Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test as a function of GP characteristics
Time Frame
5 days
Title
Patient characteristics (age, diabetes, pregnancy, nursing home)
Description
Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test according to patient characteristics,
Time Frame
5 days
Title
E.coli antimicrobial susceptibility profiles
Description
Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test based on E. coli antimicrobial susceptibility profiles
Time Frame
5 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pascal FOURNIER, Doctor
Phone
02.40.41.28.28
Email
jean-pascal.fournier@univ-nantes.fr
Facility Information:
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal FOURNIER, Doctor
Phone
02.40.41.28.28
Email
jean-pascal.fournier@univ-nantes.fr
12. IPD Sharing Statement
Learn more about this trial
Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
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