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Selective Reporting of Antibiotic Susceptibility Test Results in Urinary Tract Infections in the Outpatient Setting

NCT03612297 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 64000

Last updated 2018-08-02

No results posted yet for this study

Summary

Antibiotic resistance is a serious and increasing worldwide threat to global public health. One of antibiotic stewardship programmes' objectives is to reduce inappropriate broad-spectrum antibiotics' prescription. Selective reporting of antibiotic susceptibility test (AST) results, which consists of reporting to prescribers only few (n=5-6) antibiotics, preferring first-line and narrow-spectrum agents, is one possible strategy advised in recommendations. However, selective reporting of AST has never been evaluated using an experimental design.

This study is a pragmatic, prospective, multicentre, controlled (selective reporting vs usual complete reporting of AST), before-after (year 2019 vs 2017) study. Selective reporting of AST is scheduled to be implemented from September 2018 in the ATOUTBIO group of 21 laboratories for all E. coli identified in urine cultures in adult outpatients, and to be compared to the usual complete AST performed in the EVOLAB group of 20 laboratories. The main objective is to assess the impact of selective reporting of AST for E. coli positive urine cultures in the outpatient setting on the prescription of broad-spectrum antibiotics frequently used for urinary tract infections (amoxicillin-clavulanate, third generation cephalosporins and fluoroquinolones). The primary endpoint is the after (2019) - before (2017) difference in prescription rates for the previously mentioned antibiotics/classes that will be compared between the two laboratory groups, using linear regression models. Secondary objectives are to evaluate the feasibility of selective reporting of AST implementation by French laboratories and their acceptability by organising focus groups and individual semi-structured interviews with general practitioners and laboratory professionals.

Conditions

Interventions

DIAGNOSTIC_TEST

Selective reporting of Antibiotic Susceptibility Tests

Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults: results of susceptibility are reported back to the practitioner only for few (n=5-6) antibiotics, those that should be used in first line according to guidelines. Susceptibility results not mentioned in the selective reporting of AST are available at the practitioners' request to the microbiologist. Data used to determine which antibiotic to report for UTIs are the isolated microorganism, the patient age and gender, and antibiotics recommended in national guidelines. As guidelines for UTIs treatment differ by gender, two algorithms have been developed and pilot-tested by three GPs, one microbiologist and two infectious disease physicians.

Sponsors & Collaborators

  • University of Lorraine

    collaborator OTHER

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Céline Pulcini, Professor · Central Hospital, Nancy, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-12-31
Completion
2020-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612297 on ClinicalTrials.gov