Back to resultsModified Reporting of Positive Urine Cultures Collected From Long Term Care
Primary Purpose
Urinary Tract Infections, Asymptomatic Bacteriuria
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Modified Report
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections focused on measuring Long term care, Urine culture
Eligibility Criteria
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:
- Positive urine cultures not collected from Long term care facility patients
- Pregnancy
- Antibiotic treatment at the time of collection
- Patients known to have blood neutrophils <1.0 within 7 days of urine collection
Sites / Locations
- Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Modified Reporting
Standard Reporting
Arm Description
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"
Microbiology laboratory will report identification and susceptibility results
Outcomes
Primary Outcome Measures
Proportion of asymptomatic bacteriuria treated with antibiotics and urinary tract infection treated with antibiotics
Appropriate treatment
Secondary Outcome Measures
Adverse events
Bacteremia or death
Full Information
NCT ID
NCT03554603
First Posted
June 1, 2018
Last Updated
February 26, 2020
Sponsor
Memorial University of Newfoundland
1. Study Identification
Unique Protocol Identification Number
NCT03554603
Brief Title
Modified Reporting of Positive Urine Cultures Collected From Long Term Care
Official Title
Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Asymptomatic Bacteriuria
Keywords
Long term care, Urine culture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Reporting
Arm Type
Experimental
Arm Description
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"
Arm Title
Standard Reporting
Arm Type
No Intervention
Arm Description
Microbiology laboratory will report identification and susceptibility results
Intervention Type
Behavioral
Intervention Name(s)
Modified Report
Other Intervention Name(s)
Restricted Report
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of asymptomatic bacteriuria treated with antibiotics and urinary tract infection treated with antibiotics
Description
Appropriate treatment
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Adverse events
Description
Bacteremia or death
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Positive urine cultures not collected from Long term care facility patients
Pregnancy
Antibiotic treatment at the time of collection
Patients known to have blood neutrophils <1.0 within 7 days of urine collection
Facility Information:
Facility Name
Health Sciences Center
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Reporting of Positive Urine Cultures Collected From Long Term Care
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