NCT03612297

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

Status unknown Last updated 2 August 2018

What this trial tests

trial testing Selective reporting of Antibiotic Susceptibility Tests in Urinary Tract Infections in 64,000 participants. Status unknown.

Timeline

1 September 2018

Primary endpoint
31 December 2019

30 April 2020

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	64,000
Start date	1 September 2018
Primary completion	31 December 2019
Estimated completion	30 April 2020

Drugs / interventions tested

• Selective reporting of Antibiotic Susceptibility Tests

Conditions studied

• Urinary Tract Infections — all drugs for Urinary Tract Infections →

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Urinary Tract Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Selective reporting of antibiotic susceptibility testing results for urine cultures: feasibility and acceptability by general practitioners and laboratory professionals in France.
   Le Dref G, Simon M, Bocquier A, Fougnot S, et al · · 2023 · cited 1× · PMID 36789177 · DOI 10.1093/jacamr/dlad013