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Clinical Trials/NCT06067386
NCT06067386
Recruiting
Not Applicable

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

Nantes University Hospital1 site in 1 country3,000 target enrollmentNovember 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Tract Infections
Sponsor
Nantes University Hospital
Enrollment
3000
Locations
1
Primary Endpoint
Rate of broad-spectrum antibiotic dispensing
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 21, 2023
End Date
November 21, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • E.coli antimicrobial susceptibility profiles(5 days)
  • Patient characteristics (age, diabetes, pregnancy, nursing home)(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")(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(5 days)
  • Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)(5 days)
  • "Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy(5 days)

Study Sites (1)

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