Restricted Reporting for Positive Urine Cultures
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
February 27, 2020
CompletedFebruary 27, 2020
February 1, 2020
4 months
June 8, 2016
March 5, 2019
February 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The Number of Patients Receiving Appropriate Treatment
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
72 hours from positive culture
Study Arms (2)
Restricted Reporting
EXPERIMENTALMicrobiology 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"
Standard Reporting
NO INTERVENTIONMicrobiology laboratory will report identification and susceptibility results
Interventions
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
Eligibility Criteria
You may qualify if:
- positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.
You may not qualify if:
- pregnancy,
- antibiotic treatment at the time of urine collection,
- collection from an indwelling catheter,
- admission to long term care facility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Sciences Center
St. John's, Newfoundland and Labrador, A1B3V6, Canada
Related Publications (1)
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.
PMID: 29804552DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Our design is a proof-of-concept which will require additional trials to verify. It would be impractical to manually screen all inpatient urine specimens using our inclusion criteria, although automated eligibility screening may be possible.
Results Point of Contact
- Title
- Peter Daley
- Organization
- Memorial University
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Daley, MD FRCPC
Memorial University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 13, 2016
Study Start
January 1, 2017
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
February 27, 2020
Results First Posted
February 27, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share