- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02797613
Restricted Reporting for Positive Urine Cultures
February 26, 2020 updated by: Peter Daley, Memorial University of Newfoundland
Restricted Reporting for Positive Urine Cultures Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Newfoundland and Labrador
-
Saint John's, Newfoundland and Labrador, Canada, A1B3V6
- Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Reporting
Microbiology laboratory will report identification and susceptibility results
|
|
Experimental: Restricted 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"
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Patients Receiving Appropriate Treatment
Time Frame: 72 hours from positive culture
|
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
|
72 hours from positive culture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter Daley, MD FRCPC, Memorial University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
June 8, 2016
First Submitted That Met QC Criteria
June 10, 2016
First Posted (Estimate)
June 13, 2016
Study Record Updates
Last Update Posted (Actual)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUN-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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