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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04182230
Other study ID # CT 251053 3/07/18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2018
Est. completion date September 5, 2019

Study information

Verified date November 2019
Source Cwm Taf University Health Board (NHS)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

UROGEN WELL D-ONE

Principal research question:

Can the UROGEN WELL D-ONE assay detect urinary tract infections and urethritis in clinical samples from patients attending Genitourinary Medicine outpatient clinics as accurately as standard laboratory microscopy and culture methodologies, while simultaneously identifying antimicrobial resistance?

The primary aim of this study is to evaluate the rapid diagnostic assay UROGEN WELL D-ONE and determine if it can accurately detect infectious organisms causing UTI's and urethritis.

Secondary research question:

Is the antimicrobial resistance identified by the UROGEN WELL D-ONE assay accurate as compared to determination by the Clinical and Laboratory Standards Institute international guidelines?

The secondary research objective will be to assess the accuracy of the breakpoint antimicrobial susceptibility measurement by the assay. This is particularly important with the global increase in antibiotic resistance, when the acquisition of mobile resistance genes to the remaining effective therapeutics is rising internationally.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention. This study was an evalution with no intervention.
Not an interventional study

Locations

Country Name City State
United Kingdom Department of Sexual Health, Cwm Taf University Health board Llantrisant

Sponsors (2)

Lead Sponsor Collaborator
Cwm Taf University Health Board (NHS) Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary UROGEN WELL D-ONE PRIMARY OUTCOME The primary aim of this study is to evaluate the rapid diagnostic assay UROGEN WELL D-ONE and determine the sensitivity and specificity of the assay for the detection of sexually transmitted bacterial infections. 365 days
Secondary UROGEN WELL D-ONE SECONDARY OUTCOME To determine the specificity and sensitivity of the assay for detection of antimicrobial resistance of bacteria and compare to determination by the Clinical and Laboratory Standards Institute international guidelines. 365 days
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