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

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ClinicalTrials.gov Identifier: NCT03612297
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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.


Condition or disease Intervention/treatment
Urinary Tract Infections Diagnostic Test: Selective reporting of Antibiotic Susceptibility Tests

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 64000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Selective Reporting of Antibiotic Susceptibility Test Results in Urinary Tract Infections in the Outpatient Setting: a Protocol for a Pragmatic, Prospective Quasi-experimental Trial
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ATOUTBIO
Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults.
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.

EVOLAB
Complete reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults.



Primary Outcome Measures :
  1. Impact of selective reporting of AST for E. coli positive urine cultures in outpatient setting on the prescription of broad-spectrum antibiotics frequently used on UTIs (amoxicillin-clavulanate, third generation cephalosporins and fluoroquinolones) [ Time Frame: 2 years (1 year before + 1 year after) ]
    A comparison of the after (2019) - before (2017) difference of the prescription rates for previous mentioned antibiotics/classes between the two groups, using linear regression models adjusted for variables that differ between groups (laboratory activities, sex-ratio, age).


Secondary Outcome Measures :
  1. Laboratory expenditures (in euros) for the implementation of the intervention [ Time Frame: 2 years ]
    Collection of all laboratory expenditures made in euros in 2018 and 2019 for the implementation of the selective reporting of AST.

  2. Satisfaction of GPs and laboratory staffs about selective reporting of AST, assessed by a visual analog scale [ Time Frame: 1 year ]
    The visual analog scale is a likert scale varying from 0 to 10. Satisfaction will be collected by organizing focus groups and individual semi-structured interviews with a randomised sample of GPs and laboratory staffs one year after the selective reporting of AST implementation (September 2019).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with E. coli urinary tract infections
Criteria

Inclusion Criteria:

  • adults with an E. coli positive urine culture on which an AST is realised in the year 2017 and 2019 in ATOUTBIO or EVOLAB laboratories
  • adults who go to ambulatory care practitioners located in the geographic areas served by all the 41 laboratories studied (in the intervention ATOUTBIO group or the control EVOLAB group).

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612297


Contacts
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Contact: Céline Pulcini, Professor +33 383154097 celine.pulcini@univ-lorraine.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
University of Lorraine
Investigators
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Principal Investigator: Céline Pulcini, Professor Central Hospital, Nancy, France

Additional Information:
The World Health Organization. Antimicrobial resistance: global report on surveillance. 2014.  This link exits the ClinicalTrials.gov site Colomb-Cotinat M, Lacoste J, Coignard B, et al. Morbidité et mortalité des infections à bactéries multi-résistantes aux antibiotiques en France en 2012. Étude Burden BMR, rapport - Juin 2015. Institut de veille sanitaire. 2015  This link exits the ClinicalTrials.gov site Santé publique France. Résistance aux anti-infectieux - Données par pathogène. 2017.  This link exits the ClinicalTrials.gov site Agence nationale de sécurité du médicament et des produits de santé. L'évolution des consommations d'antibiotiques en France entre 2000 et 2015  This link exits the ClinicalTrials.gov site Société de Pathologie Infectieuse de Langue Française. Recommandations pour la prise en charge des infections urinaires bactériennes communautaires de l'adulte. 2017.  This link exits the ClinicalTrials.gov site Agence nationale de sécurité du médicament. Liste des antibiotiques critiques. 2016.  This link exits the ClinicalTrials.gov site Ministère chargé de la santé. Plan national d'alerte sur les antibiotiques. 2011-2016.  This link exits the ClinicalTrials.gov site Ministère des Solidarités et de la Santé. La mise en place d'antibiogrammes ciblés dans les infections urinaires à Escherichia coli. 2016  This link exits the ClinicalTrials.gov site European Centre for Disease Prevention and Control. EU Guidelines for the prudent use of antimicrobials in human health. 2017.  This link exits the ClinicalTrials.gov site Agence nationale de sécurité du médicament. La consommation d'antibiotiques en France en 2016.  This link exits the ClinicalTrials.gov site Agence nationale de sécurité du médicament, Santé Publique France. Consommation d'antibiotiques et résistance aux antibiotiques en France : nécessité d'une mobilisation déterminée et durable. 2016.  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03612297     History of Changes
Other Study ID Numbers: PREPS-17-0026
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Antimicrobial resistance
Antimicrobial stewardship
Selective reporting antimicrobial susceptibility tests
Escherichia coli

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Infection
Communicable Diseases
Urinary Tract Infections
Disease Susceptibility
Urologic Diseases
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Antitubercular Agents