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

NCT04182230 | Completed DMC

• 1 other identifier: CT 251053 3/07/18
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Sexually Transmitted Diseases, Bacterial; Bacterial Urinary Tract Infection; Antimicrobial Resistance

Keywords

Sexually transmitted infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• UROGEN WELL D-ONE SECONDARY OUTCOME

  365 days

Interventions

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

Not an interventional study

Eligibility Criteria

• Age: 16 Years - 100 Years
• Gender Eligibility Details: Patients identifying as male, female and transgender.
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who sexually active and attending a walk-in sexual health clinic for sexually transmitted infection testing and contraception provision.

You may qualify if:

• Participants must be sexually active. Participants will only be able to consent to this study if they have read and understood the Participant Information Sheet and been consented by a research nurse.

You may not qualify if:

• Patients aged under 16 years. Patients who are victims of sexual assault Patients who are not sexually active Patients who are deemed unable to give informed consent.

Sponsors & Collaborators

• Cwm Taf University Health Board (NHS): lead
• Cardiff University: collaborator

Study Sites (1)

Department of Sexual Health, Cwm Taf University Health board

Llantrisant, CF37 1LB, United Kingdom

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucy C Jones, DM

  Cwm Taf University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: September 5, 2018
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)