Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department

April 16, 2020 updated by: Mary Lough, Stanford University
The purpose of this study is to find the best cleaning and collection methods to obtain a 'non-contaminated' clean catch mid-stream urine sample to diagnose suspected urinary tract infection (UTI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Urinary tract infection (UTI) is a major public health issue resulting in more than 3-million visits to Emergency Departments in the United States each year. As part of the diagnostic work up, a sterile urine sample is requested for culture. The preferred urine specimen is a "Clean Catch Midstream Urine Sample". When patients are ambulatory and competent, this is a self-obtained specimen in a private bathroom. If the urine is not collected in a sterile manner the urine sample may be 'contaminated' by bacteria that originate from the skin or genital area, and not from the urinary tract. This is often described by the clinical laboratory as 'mixed growth bacteria'. A contaminated sample may lead to a false-positive urine culture result. In a non-contaminated urine specimen, only a single bacterial growth is identified as the source of the infection. Mixed bacterial flora with two or more microorganisms makes interpretation of the urine culture more difficult and prone to error. The American College of Pathologists has published results of national laboratory surveys on Urine Culture Contamination in 1998 and 2008 that document the scope of the problem.

SAMPLE: Adult ambulatory patients in the Emergency Department who have a suspected UTI and have a urine culture ordered by a physician. A total of 2000 patients will be enrolled (500 per group). This is estimated to result in 600 urine samples (150 per group). Written consent is not normally required for a self-obtained urine sample. The study will be explained and participants will verbally consent or decline to participate, as approved by the Institutional Review Board.

SETTING: Emergency Department of an academic medical center.

METHOD: This is a randomized controlled trial (RCT) with 4 groups that compare different patient self-cleaning and self-collection methods. All study supplies materials are commercially available in the United States. Each participant will be provided with study-specific visual aids for male or female participants and their randomly assigned group. The four groups are:

Group 1: Standard moist wipes and standard collection container. Group 2: Silver impregnated moist wipes and standard collection container. Group 3: Standard moist wipes and funnel collection container. Group 4: Silver impregnated moist wipes and funnel collection container. The urine samples will be sent to the Hospital Microbiology Laboratory for analysis. Urine samples with a positive leuk-esterase pre-screen will be sent for urine culture.

DATA ANALYSIS:This study is powered to detect a large effect size change in any study groups (2. 3. 4) compared with control (group 1). The sample size is sufficient to identify the method(s) with the lowest urine sample contamination rate.

Study Type

Observational

Enrollment (Actual)

1471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Ambulatory patients in the Emergency Department at an Academic Medical Center with a physician order for a urine culture. Patient must be able to self-obtain the urine culture.

Description

Inclusion Criteria:

  • 18 years of older
  • Urine culture order by physician

Exclusion Criteria:

  • Under 18 years of age
  • Urinary catheter in place
  • Not ambulatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A: Container + Castile-soap wipe
Sterile urine collection container and Castile-soap wipe given to patient to self-obtain a clean catch mid-stream urine specimen - Control group represents usual care in the Emergency Department.
Other: Container
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other Names:
  • Standard container for urine collection
Other: Castile-soap wipe
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
B: Container + Silver impregnated wipe
Sterile urine collection container and silver-impregnated cloth-wipe given to patient to self-obtain a clean catch mid-stream urine specimen
Other: Container
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other Names:
  • Standard container for urine collection
Other: Silver Impregnated Wipe
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other Names:
  • Theraworx
C: Funnel + Castile-soap wipe
Sterile urine collection funnel and Castile-soap wipe given to patient to self-obtain a clean catch mid-stream urine specimen
Other: Castile-soap wipe
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other: Funnel
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other Names:
  • Peezy Mid-stream urine collection kit
D: Funnel + Silver-impregnated wipe
Urine collection funnel and sliver impregnated cloth-wipe given to patient to self-obtain a clean catch mid-stream urine specimen
Other: Silver Impregnated Wipe
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other Names:
  • Theraworx
Other: Funnel
Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
Other Names:
  • Peezy Mid-stream urine collection kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in the number of contaminated urine cultures
Time Frame: 9 months
Contamination >10,000 CFU/mL mixed flora identified by Clinical Laboratory
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

EBLEN Charities
Forte Medical Ltd.
Avadim Technologies, Inc.

Investigators

  • Principal Investigator: Mary E. Lough, PhD, RN, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacteriuria

Clinical Trials on Container

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe