Clinical trial NCT04182230: UROGEN WELL D-ONE : Evaluation of a Novel Diagnostic for Sexually Transmitted Bacterial Infections
Official title: UROGEN WEL-DONE: Can the Novel Rapid Diagnostic UROGEN WELL D-ONE Detect Common Causes of Urinary Tract Infections and Urethritis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Diseases, Bacterial
Bacterial Urinary Tract Infection
Antimicrobial Resistance
Keywords: Sexually transmitted infections
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: Cardiff University
First posted: 2019-12-02
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: UROGEN WELL D-ONE is a new rapid culture-based benchtop diagnostic for the detection of urinary tract infections and urethritis. It detects the causative organisms and determines their antibiotic resistance. The novel test can detect bacterial infections such as E. coli, Staphylococcus spp., Enterococcus, Group B Streptococci, Mycoplasma spp, Ureaplasma spp, Neisseria spp, Gardnerella vaginalis, the protozoa Trichomonas vaginalis and Candida albicans. As such this diagnostic could be a very good tool to detect infection, identify the organism responsible for infection and with determination of antimicrobial susceptibility, guide treatment of these infections.

BACKGROUND- Urinary tract infections (UTIs) are a severe public health problem and are caused by a range of pathogens. High recurrence rates and increasing antimicrobial resistance among uropathogens threaten to greatly increase the economic burden of these infections. Urinary tract infections (UTIs) are some of the most common bacterial infections, affecting 150 million people each year worldwide1 UTIs are caused by both Gram-negative and Gram-positive bacteria, as well as by certain fungi. The most common causative agent for both uncomplicated and complicated UTIs is uropathogenic Escherichia coli (UPEC). For the agents involved in uncomplicated UTIs, UPEC is followed in prevalence by Staphylococcus saprophyticus, Enterococcus faecalis, group B Streptococcus (GBS), Neisseria spp., Staphylococcus aureus and Candida spp.2-5 Multidrug-resistant uropathogenic organisms are becoming an expanding public health threat, as Enterobacteriaceae family members increasingly acquire extended-spectrum β-lactamases, such as cefotaximases, oxacillinases, AmpC-type β-lactamases and carbapenemases.8-9. Routine testing techniques currently used for antibiotic sensitivity of pathogens causing UTIs can take 2-3 days to perform and so accurate treatment is often delayed. This delays treatment and can lead to increased morbidity.

Urethritis or inflammation of the urethra, is a multifactorial condition which is sexually acquired in the majority of (but not all) cases. It is characterised by urethral discharge, dysuria and/or urethral discomfort. Urethritis is described as either gonococcal, when Neisseria gonorrhoeae is detected, or nongonococcal (NGU) when it is not. Organisms implicated in this disease are commonly Chlamydia trachomatis, Mycoplasma spp, Ureaplasma spp, Trichomonas vaginalis and Candida. A number of studies indicate that antibiotic resistance in some of these organisms leads to microbiological failure of treatment, up to 68% for tetracyclines.11,13,14 , up to 33% for macrolides 10,11,13-18 and that mutations in the quinolone-resistance determining regions (QRDRs) of the gyrA and parC genes can occur with a prevalence of 10%19. Persistent NGU, when symptoms do not resolve following treatment, occurs in 15%-25% of patients following initial treatment of acute NGU. Recurrent NGU is empirically defined as the recurrence occurs in 10%-20% of patients.12,20 The aetiology of persistent NGU is probably multifactorial with a persistent infectious agent being identified in 50% of cases.11,12,20,21 Currently, testing for the detection of UTI and urethritis is expensive, requires highly trained laboratory staff and takes 48-72 hours. This delays treatment and can lead to increased morbidity. However, UROGEN WELL D-ONE is a new rapid culture-based clinical diagnostic assay, which will improve clinical provision for the detection of the cause of urinary tract infections and urethritis from urine samples e.g E. coli, Gardnerella vaginalis, Group B Streptococcus, Staphylococcus aureus, Neisseria spp., Enterococcus, E. Coli, Mycoplasma and Ureaplasma spp, the protozoa Trichomonas vaginalis and Candida albicans. It will also demonstrate their antimicrobial susceptibility. Importantly it uses the correct CLSI antibiotic threshold concentrations to determine antimicrobial resistance and does not require specialist equipment.

In summary, UROGEN WELL D-ONE has the potential to allow rapid detection of the common organisms that cause UTI and urethritis and guide antibiotic treatment, with a turnaround time of 18 hours. This has highly significant positive outcomes for patients and reduce empirical treatment of infection.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: UROGEN WELL D-ONE PRIMARY OUTCOME
timeFrame: 365 days
Secondary outcomes:
measure: UROGEN WELL D-ONE SECONDARY OUTCOME
timeFrame: 365 days
Other outcomes:
Locations:
city: Llantrisant
country: United Kingdom
facility: Department of Sexual Health, Cwm Taf University Health board
Study officials:
affiliation: Cwm Taf University Health Board
name: Lucy C Jones, DM
role: PRINCIPAL_INVESTIGATOR
References: