Back to resultsRestricted Reporting for Positive Urine Cultures
Primary Purpose
Bacteriuria, Urinary Tract Infection
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Restricted Reporting
Sponsored by
About this trial
This is an interventional treatment trial for Bacteriuria
Eligibility Criteria
Inclusion Criteria:
- positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.
Exclusion Criteria:
- pregnancy,
- antibiotic treatment at the time of urine collection,
- collection from an indwelling catheter,
- admission to long term care facility.
Sites / Locations
- Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Restricted 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
The Number of Patients Receiving Appropriate Treatment
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
Secondary Outcome Measures
Full Information
NCT ID
NCT02797613
First Posted
June 8, 2016
Last Updated
February 26, 2020
Sponsor
Memorial University of Newfoundland
1. Study Identification
Unique Protocol Identification Number
NCT02797613
Brief Title
Restricted Reporting for Positive Urine Cultures
Official Title
Restricted Reporting for Positive Urine Cultures Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (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
Bacteriuria, Urinary Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restricted 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)
Restricted Reporting
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
The Number of Patients Receiving Appropriate Treatment
Description
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
Time Frame
72 hours from positive culture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.
Exclusion Criteria:
pregnancy,
antibiotic treatment at the time of urine collection,
collection from an indwelling catheter,
admission to long term care facility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Daley, MD FRCPC
Organizational Affiliation
Memorial University
Official's Role
Principal Investigator
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
Citations:
PubMed Identifier
29804552
Citation
Daley P, Garcia D, Inayatullah R, Penney C, Boyd S. Modified Reporting of Positive Urine Cultures to Reduce Inappropriate Treatment of Asymptomatic Bacteriuria Among Nonpregnant, Noncatheterized Inpatients: A Randomized Controlled Trial. Infect Control Hosp Epidemiol. 2018 Jul;39(7):814-819. doi: 10.1017/ice.2018.100. Epub 2018 May 28.
Results Reference
derived
Learn more about this trial
Restricted Reporting for Positive Urine Cultures
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