Safety and Effectiveness of a Laboratory Intervention to Effectively NOT Treat Asymptomatic Bacteriuria
Salient
1 other identifier
observational
1,394
1 country
1
Brief Summary
This is an observational cohort study of 1000 consecutive patients on medical and surgical wards at the Mount Sinai Hospital in Toronto who have a mid-stream urine culture ordered. When these cultures are ordered or received in the laboratory, a message is posted that the specimen will not be processed in the laboratory unless a call is received to say that the patient has local urinary symptoms. The goal is to establish whether not processing mid-stream urine cultures is safe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
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
Study Start
First participant enrolled
August 31, 2017
CompletedFirst Submitted
Initial submission to the registry
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2019
CompletedJune 1, 2020
May 1, 2020
1.7 years
February 20, 2018
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
serious adverse events (SAE) associated with not processing urine culture
serious adverse events associated with not processing urine culture
30 days
Secondary Outcomes (3)
Differences in SAE
30 days
SAE due to antibiotics
30 days
Non-response
4 days
Study Arms (1)
study cohort
All non-ICU medicine and surgery patients at Sinai Health System who have a mid-stream urine culture ordered
Interventions
microbiology lab will not process culture unless called
Eligibility Criteria
All inpatients on medical and surgical units who have a mid-stream urine culture ordered
You may qualify if:
- inpatients on medical or surgical units at Mount Sinai Hospital
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison McGeer
Sinai Health System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Infection Prevention and Control
Study Record Dates
First Submitted
February 20, 2018
First Posted
February 26, 2018
Study Start
August 31, 2017
Primary Completion
May 15, 2019
Study Completion
November 15, 2019
Last Updated
June 1, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
individual patient data will not be available to other researchers. This is a quality improvement study