MicroUDxTM: a Rapid Diagnostic Tool That Will Prevent Death and Disability From Common Infections

NCT04228081 | Unknown

• 1 other identifier: REB19-00442
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background \& Rational: Antibiotics are a major underpinning of modern medicine. The global rise of antimicrobial resistant (AMR) organisms is a serious world health problem. With few new antimicrobial drugs on the horizon, it is imperative that we develop novel approaches to extend the service life of our existing drugs. AMR is a complex problem that is being driven by a wide range of factors. More than half of the antibiotics prescribed have no medical benefit, and outpatient visits for uncomplicated urinary tract infections (UTIs) are a major contributor to this problem. Recent studies have shown that nearly half of people treated for UTIs receive the wrong frontline drug and in 75% of patients, the duration of therapy is inappropriate. Limitations in the current diagnostic technology make it impossible to identify UTI pathogens and measure their antibiotic sensitivities during the short out-patient clinical visits that are typical for most UTI patients. These circumstances result in the inappropriate use of stronger than necessary or inappropriate antimicrobials. The aim of this study is to develop and evaluate a system that can detect bacteria in urine and find the best antibiotic in under 4 hours, thus enabling a rapid diagnosis and use of the most appropriate and cost-effective antimicrobial agent for the agent detected.

Conditions

Bacterial Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Assay ID Validation

  In the validation phase of the study sensitivity, specificity and positive and negative predictive values for detecting significant bacteriuria using culture as the gold standard, These values will be calculated for the whole cohort as per standard definitions using statistical software (Analyse-it for Excel).

  2 years

Secondary Outcomes (2)

• Susceptibility - anti-microbial susceptibility of new assay versus standard laboratory methods

  2 years

• Turn-around-time to bacterial detection and susceptibility

  2 years

Study Arms (2)

UTI Positive

In phase I of the study testing residual urine samples the aim is to include at least 50 positive samples from each bacterial species known to be commonly associated with urinary tract infections. We selected 2000 positive urines to enable capturing enough of these organisms in the development process. For phase II of the study, the same number of positive samples in order to include all common species causing urinary tract infection. The number of negative samples included is reduced to 1000. Phase 3 - approximately one third of all urine sample submitted will be positive for a uropathogen. Sample size of 3000 we expect 1000 these to be culture positive. We expect most uropathogens occurring at a frequency of 5% or more will be included with sufficient numbers in the validation process.

UTI Negative Control

2000 negative urine samples are being run as controlled to ensure the false positivity rate is low.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The majority of urine samples collected in Calgary coming from young healthy females with symptoms of cystitis or pyelonephritis. However, residual sample from any patient where a urine culture has been ordered could be included in the study if it falls within the time during which residual samples are being processed.

You may qualify if:

• Patients who have not submitted urine samples will not be included as the samples are required for both standard testing and research. This would include patients who are being treated empirically by physicians.

You may not qualify if:

• Patient's who have not submitted urine samples for culture will not be included in study.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

research samples will be stored in a equal volume of 100% methanol in a -80 freezer at the Diagnostic and Scientific Centre or at the Lewis Lab in Biological Sciences U of C.

Study Officials

• Ian A Lewis, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian A Lewis, PhD

CONTACT

403-220-4366; ian.lewis2@ucalgary.ca

Troy D Feener, MSc

CONTACT

403-870-1201; tdfeener@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 15, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)