NCT03554603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 1, 2018

Results QC Date

September 5, 2022

Last Update Submit

July 26, 2023

Conditions

Keywords

Long term careUrine culture

Outcome Measures

Primary Outcomes (1)

  • Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics

    Number of Participants Who Received Appropriate Antibiotic Treatment

    7 days

Study Arms (2)

Modified Reporting

EXPERIMENTAL

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: Modified Report

Standard Reporting

NO INTERVENTION

Microbiology laboratory will report identification and susceptibility results

Interventions

Modified ReportBEHAVIORAL

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.

Also known as: Restricted Report
Modified Reporting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).

You may not qualify if:

  • Positive urine cultures not collected from Long term care facility patients
  • Pregnancy
  • Antibiotic treatment at the time of collection
  • Patients known to have blood neutrophils \<1.0 within 7 days of urine collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Center

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

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Peter Daley MD MSc
Organization
Memorial University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 13, 2018

Study Start

November 5, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 1, 2024

Results First Posted

March 1, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations