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Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs

Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06067386
Acronym
ABC-MG
Enrollment
3000
Registered
2023-10-04
Start date
2023-11-21
Completion date
2024-11-21
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Antibiotic therapy, General practice, Primary care, Public health

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.

Interventions

OTHERDissemination of a selective reporting for antibiotic susceptibility testing

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.

OTHERStandard antibiotic susceptibility testing report

GPs will receive a standard antibiotic susceptibility testing report for each E. coli positive urine culture.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of broad-spectrum antibiotic dispensing5 daysThe 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

MeasureTime frameDescription
Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)5 daysThis 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 therapy5 days
E.coli antimicrobial susceptibility profiles5 daysImpact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test based on E. coli antimicrobial susceptibility profiles
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 declared5 daysImpact 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)5 daysImpact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test according to patient characteristics,
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)5 days

Countries

France

Contacts

Primary ContactJean-Pascal FOURNIER, Doctor
jean-pascal.fournier@univ-nantes.fr02.40.41.28.28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026