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

NCT ID: NCT06067386

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2024-11-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

Dissemination of a selective reporting for antibiotic susceptibility testing

Intervention Type: 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.

Control arm

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

Group Type: ACTIVE_COMPARATOR

Standard antibiotic susceptibility testing report

Intervention Type: OTHER

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

Interventions

Dissemination 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.

Intervention Type: OTHER

Standard antibiotic susceptibility testing report

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Nantes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Pascal FOURNIER, Doctor

Role: CONTACT

jean-pascal.fournier@univ-nantes.fr

02.40.41.28.28

Facility Contacts

Jean-Pascal FOURNIER, Doctor

Role: primary

jean-pascal.fournier@univ-nantes.fr

02.40.41.28.28

Other Identifiers

RC22_0003

Identifier Type: -

Identifier Source: org_study_id