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Restricted Reporting for Positive Urine Cultures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02797613
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
Peter Daley, Memorial University of Newfoundland

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.

Condition or disease Intervention/treatment Phase
Bacteriuria Urinary Tract Infection Behavioral: Restricted Reporting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Restricted Reporting for Positive Urine Cultures Randomized Controlled Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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"
Behavioral: Restricted Reporting
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

No Intervention: Standard Reporting
Microbiology laboratory will report identification and susceptibility results

Primary Outcome Measures :
  1. Proportion of asymptomatic bacteriuria treated with antibiotics [ Time Frame: 7 days from positive culture ]

Secondary Outcome Measures :
  1. Adverse events (pyelonephritis or sepsis) [ Time Frame: 7 days from positive culture ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02797613

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Canada, Newfoundland and Labrador
Health Sciences Center
Saint John's, Newfoundland and Labrador, Canada, A1B3V6
Sponsors and Collaborators
Memorial University of Newfoundland
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Principal Investigator: Peter Daley, MD FRCPC Memorial University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter Daley, Assistant Professor, Memorial University of Newfoundland Identifier: NCT02797613     History of Changes
Other Study ID Numbers: MUN-01
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Urologic Diseases