Clinical trial NCT06067386: Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
Official title: Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Antibiotic therapy
General practice
Primary care
Public health
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Rate of broad-spectrum antibiotic dispensing
timeFrame: 5 days
Secondary outcomes:
measure: Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)
timeFrame: 5 days
measure: "Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy
timeFrame: 5 days
measure: 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")
timeFrame: 5 days
measure: 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
timeFrame: 5 days
measure: Patient characteristics (age, diabetes, pregnancy, nursing home)
timeFrame: 5 days
measure: E.coli antimicrobial susceptibility profiles
timeFrame: 5 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References: