UROGEN WELL D-ONE
Research type
Research Study
Full title
UROGEN WELL D-ONE: Can the novel rapid diagnostic UROGEN WELL D-ONE detect common causes of urinary tract infections and urethritis?
IRAS ID
251053
Contact name
Lucy Jones
Contact email
Sponsor organisation
Cwm Taf University Health Board
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
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 worldwide. UTIs are caused by several types of bacteria, as well as by certain fungi. Routine testing techniques currently used for detection of pathogens causing UTIs and any antibiotic resistance can take 2-3 days to perform and so accurate treatment is often delayed 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, up to 33% for macrolides and that mutations in the quinolone-resistance determining regions (QRDRs) of the gyrA and parC genes can occur with a prevalence of 10%. 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.The aetiology of persistent NGU is probably multifactorial with a persistent infectious agent being identified in 50% of cases.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.
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.REC name
Wales REC 7
REC reference
18/WA/0296
Date of REC Opinion
5 Sep 2018
REC opinion
Favourable Opinion