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Trial record 88 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Safety and Effectiveness of a Laboratory Intervention to Effectively NOT Treat Asymptomatic Bacteriuria (Salient)

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ClinicalTrials.gov Identifier: NCT03445312
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Allison McGeer, Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment
Asymptomatic Bacteriuria Urinary Tract Infections Behavioral: not processing urine cultures

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Effectiveness of a Laboratory Intervention to Effectively NOT Treat Asymptomatic Bacteriuria (SALIENT-A)
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study cohort
All non-ICU medicine and surgery patients at Sinai Health System who have a mid-stream urine culture ordered
Behavioral: not processing urine cultures
microbiology lab will not process culture unless called




Primary Outcome Measures :
  1. serious adverse events (SAE) associated with not processing urine culture [ Time Frame: 30 days ]
    serious adverse events associated with not processing urine culture


Secondary Outcome Measures :
  1. Differences in SAE [ Time Frame: 30 days ]
    Rate of serious adverse events in patients without symptoms who did and did not have urine specimens processed

  2. SAE due to antibiotics [ Time Frame: 30 days ]
    Rate of serious adverse events due to antibiotic therapy in patients who received antibiotics for asymptomatic bacteriuria

  3. Non-response [ Time Frame: 4 days ]
    Proportion of patients with symptomatic urinary tract infection (UTI) who did not respond to initial empiric antibiotics



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All inpatients on medical and surgical units who have a mid-stream urine culture ordered
Criteria

Inclusion Criteria:

  • inpatients on medical or surgical units at Mount Sinai Hospital

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445312


Contacts
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Contact: Allison McGeer, MD 416-586-3118 amcgeer@mtsinai.on.ca
Contact: Liz Mccreight 416-586-3118 lmccreight@mtsinai.on.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Allison McGeer    416-586-3118    amcgeer@mtsinai.on.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Allison McGeer Sinai Health System

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Responsible Party: Allison McGeer, Medical Director, Infection Prevention and Control, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03445312     History of Changes
Other Study ID Numbers: MSH 16-0302E
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual patient data will not be available to other researchers. This is a quality improvement study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Tract Infections
Bacteriuria
Infection
Urologic Diseases