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

Urinary Tract Infections Clinical Trial

— ABC-MG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067386
• Other study ID #: RC22_0003
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: November 21, 2024

Study information

• Verified date: September 2023
• Source: Nantes University Hospital
• Contact: Jean-Pascal FOURNIER, Doctor
• Phone: 02.40.41.28.28
• Email: jean-pascal.fournier[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 21, 2024
• Est. primary completion date: November 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of directed broad-spectrum antibiotic dispensing (=within 5 days after report of the antibiotic susceptibility testing)	This analysis will be restricted to women who have received no empirical antibiotic therapy (=within 3 days before report of the antibiotic susceptibility testing)	5 days
Secondary	"Antibiotic de-escalation" rate: modification of an empirical broad-spectrum antibiotic therapy to a directed narrow-spectrum antibiotic therapy		5 days
Secondary	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
Secondary	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	Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test as a function of GP characteristics	5 days
Secondary	Patient characteristics (age, diabetes, pregnancy, nursing home)	Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test according to patient characteristics,	5 days
Secondary	E.coli antimicrobial susceptibility profiles	Impact of targeted antibiotic susceptibility testing compared to of a standard antibiotic susceptibility test based on E. coli antimicrobial susceptibility profiles	5 days