Modified Reporting From Indwelling Catheters

NCT03488355 | Completed Results

• 1 other identifier: MUN-3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Catheter

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Appropriate Treatment

  Untreated catheter-associated asymptomatic bacteriurias, plus treated catheter-associated urinary tract infections, divided by total patients.

  7 days after positive urine culture

Secondary Outcomes (2)

• Death

  7 days

• Adverse Events

  7 days after positive urine culture

Study Arms (2)

Modified Reporting

EXPERIMENTAL

Modified laboratory report

Other: Modified laboratory report

Standard Reporting

NO INTERVENTION

Standard laboratory report

Interventions

Modified laboratory report OTHER

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."

Modified Reporting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Health Sciences Center

St. John's, Newfoundland and Labrador, A1B3V6, Canada

Location

Related Publications (1)

• Pratt CL, Rehan Z, Xing L, Gilbert L, Fillier B, Barrett B, Daley P. Modified reporting of positive urine cultures to reduce inappropriate antibiotic treatment of catheter-associated asymptomatic bacteriuria (CA-ASB) among inpatients, a randomized controlled trial. Infect Control Hosp Epidemiol. 2021 Oct;42(10):1221-1227. doi: 10.1017/ice.2020.1397. Epub 2021 Jun 4.

  PMID: 34085614 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Peter Daley
• Organization: Memorial University of Newfoundland

pkd336@mun.ca

7097772089

Study Officials

• Brendan Barrett, MD

  Memorial University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 5, 2018
• Study Start: November 5, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)