Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04182230
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2019-11-27
Brief Title:
UROGEN WELL D-ONE Evaluation of a Novel Diagnostic for Sexually Transmitted Bacterial Infections
Sponsor:
Cwm Taf University Health Board NHS
Organization:
Cwm Taf University Health Board NHS
Study Overview
Official Title:
UROGEN WEL-DONE Can the Novel Rapid Diagnostic UROGEN WELL D-ONE Detect Common Causes of Urinary Tract Infections and Urethritis
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 UTIs 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
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 UTIs 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 spp2-5 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 carbapenemases8-9 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 andor 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 tetracyclines111314 up to 33 for macrolides 101113-18 and that mutations in the quinolone-resistance determining regions QRDRs of the gyrA and parC genes can occur with a prevalence of 1019 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 patients1220 The aetiology of persistent NGU is probably multifactorial with a persistent infectious agent being identified in 50 of cases11122021 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 eg 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
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 spp2-5 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 carbapenemases8-9 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 andor 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 tetracyclines111314 up to 33 for macrolides 101113-18 and that mutations in the quinolone-resistance determining regions QRDRs of the gyrA and parC genes can occur with a prevalence of 1019 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 patients1220 The aetiology of persistent NGU is probably multifactorial with a persistent infectious agent being identified in 50 of cases11122021 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None