Working… Menu

Modified Reporting From Indwelling Catheters

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: NCT03488355
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : August 13, 2019
Information provided by (Responsible Party):
Peter Daley, Memorial University of Newfoundland

Brief Summary:
Positive urine cultures collected from indwelling catheters from inpatients will be randomized to standard reporting or modified reporting. Physician antibiotic treatment decisions will be prospectively observed and determined to be appropriate or inappropriate. The hypothesis is that modified reporting will lead to an increase in the percentage of appropriate therapy without an increase in pyelonephritis or sepsis.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Other: Modified laboratory report Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Modified Reporting of Positive Urine Cultures Collected From Indwelling Catheters, a Randomized Controlled Trial
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Modified Reporting
Modified laboratory report
Other: Modified laboratory report
Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."

No Intervention: Standard Reporting
Standard laboratory report

Primary Outcome Measures :
  1. Proportion of inappropriate antibiotic therapy prescribed by physicians (efficacy) [ Time Frame: 72 hours after urine collection ]
    As assessed by investigator based on investigator's diagnosis of asymptomatic bacteriuria (should not be treated) or urinary tract infection (should be treated).

Secondary Outcome Measures :
  1. Adverse events (safety) [ Time Frame: 7 days ]
    Untreated bacteremia or death

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • consecutive positive urine cultures collected from indwelling catheters in inpatients that are greater than or equal to 18 years of age.
  • admitted to Health Sciences Center or St. Clare's Mercy hospitals only

Exclusion Criteria:

  • pregnancy
  • antibiotic treatment at the time of collection
  • patients in the Intensive Care Unit
  • blood neutrophils count <1.0 x 10E9/l, within 7 days of urine collection

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): NCT03488355

Layout table for location information
Canada, Newfoundland and Labrador
Health Sciences Center
Saint John's, Newfoundland and Labrador, Canada, A1B3V6
Sponsors and Collaborators
Memorial University of Newfoundland
Layout table for investigator information
Principal Investigator: Brendan Barrett, MD Memorial University

Layout table for additonal information
Responsible Party: Peter Daley, Associate Professor, Memorial University of Newfoundland Identifier: NCT03488355     History of Changes
Other Study ID Numbers: MUN-3
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Daley, Memorial University of Newfoundland:
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Tract Infections
Urologic Diseases