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UROGEN WELL D-ONE : Evaluation of a Novel Diagnostic for Sexually Transmitted Bacterial Infections

NCT04182230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-12-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No intervention. This study was an evalution with no intervention.

Not an interventional study

Sponsors & Collaborators

  • Cardiff University

    collaborator OTHER

  • Cwm Taf University Health Board (NHS)

    lead OTHER_GOV

Principal Investigators

  • Lucy C Jones, DM · Cwm Taf University Health Board

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2019-09-05
Completion
2019-09-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182230 on ClinicalTrials.gov