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Modified Reporting of Positive Urine Cultures Collected From Long Term Care

Sponsor
Memorial University of Newfoundland (Other)
Overall Status
Completed
CT.gov ID
NCT03554603
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
8.8
Actual Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Modified Report
 N/A

Detailed Description

Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial
Actual Study Start Date :
Nov 5, 2018
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Modified Reporting

Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"

Behavioral: Modified Report
An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.
Other Names:
  • Restricted Report

    		•
    No Intervention: Standard Reporting

    Microbiology laboratory will report identification and susceptibility results

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of asymptomatic bacteriuria treated with antibiotics and urinary tract infection treated with antibiotics [7 days]

      Appropriate treatment

    Secondary Outcome Measures

    1. Adverse events [30 days]

      Bacteremia or death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).
    Exclusion Criteria:

    1. Positive urine cultures not collected from Long term care facility patients

    2. Pregnancy

    3. Antibiotic treatment at the time of collection

    4. Patients known to have blood neutrophils <1.0 within 7 days of urine collection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Health Sciences Center Saint John's Newfoundland and Labrador Canada A1B3V6

    Sponsors and Collaborators

    • Memorial University of Newfoundland

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Daley, Associate Professor, Memorial University of Newfoundland
    ClinicalTrials.gov Identifier:
    NCT03554603
    Other Study ID Numbers:
    • MUN-04
    First Posted:
    Jun 13, 2018
    Last Update Posted:
    Feb 27, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peter Daley, Associate Professor, Memorial University of Newfoundland
    Long term care
    Urine culture
    Additional relevant MeSH terms:
    Urinary Tract Infections
    Bacteriuria

    Study Results

    No Results Posted as of Feb 27, 2020