Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625268
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections Diagnostic Accuracy in General Practice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Machbarkeit Und Explorative Validierung Des PA-100-AST-Systems Bei Frauen Mit Verdacht Auf Eine Unkomplizierte Harnwergsinfektion in Der Hausarztpraxis - Eine Pilotstudie
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study adult women presenting at their general practitioner with a likely bladder infection with symptoms like a burning sensation when urinating pain in the lower abdomen and frequent or urgent need to urinate will be invited After informed consent women provide a urine sample which is tested using a new system called the PA-100-AST from the manufacturer Sysmex This point-of-care test showed first evidence to be able to quickly detect the presence of bacteria commonly responsible for bladder infections If bacteria are found the test also checks which antibiotics may work best to treat the infection Additionally a sample of the urine is sent to a lab for a traditional culture test which is considered the most accurate method The goal of this study is to compare the accuracy of the PA-100-AST system to the lab-based test to see how well it works in general practice
Detailed Description:
The PA-100-AST urine analyzer from Sysmex is a rapid point-of-care test currently registered as a medicinal product The system identifies bacteriuria 50000 CFUmL and reports antibiotic susceptibility results as susceptible S susceptible with increased exposure I resistant R or not applicable NA for amoxicillinclavulanic acid ciprofloxacin fosfomycin nitrofurantoin and trimethoprim based on EUCAST standards Although the system detects bacteriuria it does not inform the user of the specific bacterial species involved providing only a positive or negative result
The PA-100 cartridge is designed to detect common uropathogens Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterococcus faecalis and Staphylococcus saprophyticus A proprietary internal algorithm classifies bacteria into one of three groups Enterobacterales Staphylococcus or Enterococcus and applies appropriate EUCAST breakpoints
This product is authorized and CE-marked in the European Union for point-of-care use in women with suspected uncomplicated urinary tract infections UTIs
However the PA-100-AST system has not yet been evaluated in a general practice setting The goal of this study is to compare the results of the Sysmex PA-100-AST with laboratory-based urine culture in a consecutive sample of adult women recruited from general practices
Recruitment Adult non-pregnant women with symptoms suggestive of uncomplicated UTI will be recruited consecutively and prospectively during routine consultations in at least four general practices across two German practice-based research networks Bavaria and Thuringia Informed consent will be obtained from all participants
Outcomes The primary outcome measure is diagnostic accuracy compared with urine culture Urine culture positivity is defined as a bacterial count of at least 50000 CFUml per the instructions for use of one of the species detected by the PA-100-AST index test Additionally the diagnostic accuracy of the index test will be assessed against varying thresholds for urine culture positivity from 1000 to 100000 CFUml or greater
Another key outcome is the agreement between the susceptibility test results from the index test and the reference laboratory-based susceptibility test Exploratory subgroup analyses will include assessments based on age dipstick test results and symptom severity at presentation
Data Collection The index test will be conducted immediately after enrolment on fresh urine within 30 minutes of collection A pragmatic approach will be followed with microbiological analysis carried out by the laboratories that typically serve the participating practices These laboratories adhere to common quality standards according to the German laboratory guidelines Harnwegsinfektionen Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik MIQ-02 and apply EUCAST criteria for susceptibility testing According to STARD recommendations clinicians performing the index test as well as laboratory technicians and microbiologists conducting the urine culture are blinded to the results of each others tests Clinical data are collected using a validated patient questionnaire at the initial presentation PMID 33589460 and management decisions are recorded during routine consultation Dipstick test results are measured through Combur test stripes Roche Diagnostics
Data Analysis Descriptive statistics will be presented using appropriate summary measures such as mean SD median IQR and absolute and relative frequencies
Diagnostic accuracy measures sensitivity specificity predictive values and likelihood ratios will be reported with corresponding 95 confidence intervals
Kappa coefficients and corresponding statistical tests will be used to assess agreement between categorical variables with statistical significance set at p less than 005 for susceptibility test results
Sample Size The initial sample size calculation assumed a sensitivity of 988 and specificity of 984 based on manufacturer data Given a prevalence of 70 we estimated that 101 patients would be required to estimate specificity and 51 patients to estimate sensitivity with a 95 confidence interval CI width of 01 However after the protocol was approved a clinical evaluation in a hospital setting PMID 38825624 was published reporting a sensitivity of 84 and a specificity of 994 for the PA-100-AST using a threshold of 50000 CFUml as per the instructions for use Given the more realistic estimates from this study the sample size was recalculated Based on the revised sensitivity and specificity estimates and a 50000 CFUml culture positivity threshold for which a decreased prevalence from 070 to 060 can be expected the required sample size increased from 101 to 345 participants Due to no project-specific funding and in agreement with the sponsor this was deemed unfeasible Therefore the aim to recruit 200 participants which under the assumption outlined above will result in a 95CI width of 013 instead of the initially planned width of 01
Role of manufacturer
This study is investigator-initiated Sysmex has provided the urine analyzer free of charge but has no involvement in the study design implementation aside from supplying detailed instructions for use as well as technical assistance data preparation analysis interpretation or publication of results None of the investigators receive any funding or benefits from Sysmex or other device manufacturers
The PA-100 cartridge is designed to detect common uropathogens Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterococcus faecalis and Staphylococcus saprophyticus A proprietary internal algorithm classifies bacteria into one of three groups Enterobacterales Staphylococcus or Enterococcus and applies appropriate EUCAST breakpoints
This product is authorized and CE-marked in the European Union for point-of-care use in women with suspected uncomplicated urinary tract infections UTIs
However the PA-100-AST system has not yet been evaluated in a general practice setting The goal of this study is to compare the results of the Sysmex PA-100-AST with laboratory-based urine culture in a consecutive sample of adult women recruited from general practices
Recruitment Adult non-pregnant women with symptoms suggestive of uncomplicated UTI will be recruited consecutively and prospectively during routine consultations in at least four general practices across two German practice-based research networks Bavaria and Thuringia Informed consent will be obtained from all participants
Outcomes The primary outcome measure is diagnostic accuracy compared with urine culture Urine culture positivity is defined as a bacterial count of at least 50000 CFUml per the instructions for use of one of the species detected by the PA-100-AST index test Additionally the diagnostic accuracy of the index test will be assessed against varying thresholds for urine culture positivity from 1000 to 100000 CFUml or greater
Another key outcome is the agreement between the susceptibility test results from the index test and the reference laboratory-based susceptibility test Exploratory subgroup analyses will include assessments based on age dipstick test results and symptom severity at presentation
Data Collection The index test will be conducted immediately after enrolment on fresh urine within 30 minutes of collection A pragmatic approach will be followed with microbiological analysis carried out by the laboratories that typically serve the participating practices These laboratories adhere to common quality standards according to the German laboratory guidelines Harnwegsinfektionen Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik MIQ-02 and apply EUCAST criteria for susceptibility testing According to STARD recommendations clinicians performing the index test as well as laboratory technicians and microbiologists conducting the urine culture are blinded to the results of each others tests Clinical data are collected using a validated patient questionnaire at the initial presentation PMID 33589460 and management decisions are recorded during routine consultation Dipstick test results are measured through Combur test stripes Roche Diagnostics
Data Analysis Descriptive statistics will be presented using appropriate summary measures such as mean SD median IQR and absolute and relative frequencies
Diagnostic accuracy measures sensitivity specificity predictive values and likelihood ratios will be reported with corresponding 95 confidence intervals
Kappa coefficients and corresponding statistical tests will be used to assess agreement between categorical variables with statistical significance set at p less than 005 for susceptibility test results
Sample Size The initial sample size calculation assumed a sensitivity of 988 and specificity of 984 based on manufacturer data Given a prevalence of 70 we estimated that 101 patients would be required to estimate specificity and 51 patients to estimate sensitivity with a 95 confidence interval CI width of 01 However after the protocol was approved a clinical evaluation in a hospital setting PMID 38825624 was published reporting a sensitivity of 84 and a specificity of 994 for the PA-100-AST using a threshold of 50000 CFUml as per the instructions for use Given the more realistic estimates from this study the sample size was recalculated Based on the revised sensitivity and specificity estimates and a 50000 CFUml culture positivity threshold for which a decreased prevalence from 070 to 060 can be expected the required sample size increased from 101 to 345 participants Due to no project-specific funding and in agreement with the sponsor this was deemed unfeasible Therefore the aim to recruit 200 participants which under the assumption outlined above will result in a 95CI width of 013 instead of the initially planned width of 01
Role of manufacturer
This study is investigator-initiated Sysmex has provided the urine analyzer free of charge but has no involvement in the study design implementation aside from supplying detailed instructions for use as well as technical assistance data preparation analysis interpretation or publication of results None of the investigators receive any funding or benefits from Sysmex or other device manufacturers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None