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

NCT06067386 | Unknown

• 1 other identifier: RC22_0003
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Antibiotic therapy; General practice; Primary care; Public health

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (6)

• 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

• 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

• Patient characteristics (age, diabetes, pregnancy, nursing home)

  5 days

Study Arms (2)

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.

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.

Other: Standard antibiotic susceptibility testing report

Interventions

Dissemination of a selective reporting for antibiotic susceptibility testing OTHER

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 arm

Standard antibiotic susceptibility testing report OTHER

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

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Jean-Pascal FOURNIER, Doctor

CONTACT

02.40.41.28.28; jean-pascal.fournier@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 4, 2023
• Study Start: November 21, 2023
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: April 22, 2024

Record last verified: 2023-09

Locations

FR (1)