Actively Recruiting

Age: 18Years +
FEMALE
ID06625268

Rapid Point-of-care Bacteriuria and Microbial Susceptibility Testing in Women With Suspected Uncomplicated Urinary Tract Infections in General Practice

Led by Wuerzburg University Hospital · Updated on 2025-02-17

200

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

W

Wuerzburg University Hospital

Lead Sponsor

J

Jena University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on adult women who visit their general practitioner with symptoms suggesting a bladder infection, such as burning during urination, lower abdominal pain, and frequent or urgent urination. The study aims to evaluate the accuracy of a new point-of-care urine test system called PA-100-AST from Sysmex, comparing it to the traditional laboratory urine culture test. This observational study is conducted in general practice settings to see how well the PA-100-AST performs for diagnosing uncomplicated urinary tract infections in women. The PA-100-AST system rapidly detects bacteria in urine and reports antibiotic susceptibility for common antibiotics used to treat urinary tract infections. It identifies bacterial groups but does not specify exact bacterial species. Urine samples are tested immediately after collection with the PA-100-AST, and additional samples are sent to labs for standard culture tests. The study involves adult women suspected of uncomplicated UTIs visiting several general practices, with all testing done under routine conditions. Participants provide urine samples and complete a questionnaire at their initial visit. Researchers collect clinical data, dipstick test results, and antibiotic susceptibility information. The main outcome measures include the test's sensitivity, specificity, predictive values, and likelihood ratios compared to the lab culture. The study also explores agreement between the PA-100-AST and lab susceptibility results. Participation involves routine consultations, and results help assess the new test's usefulness in general practice.

CONDITIONS

Brief Title

Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice.

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age 18 years or older
  • Clinically suspected uncomplicated urinary tract infection by a general practitioner
Not Eligible

You will not qualify if you...

  • Use of a urinary catheter
  • Severe urinary tract abnormalities such as cancer or strictures
  • Immunosuppression, including chronic immunosuppressant use or AIDS
  • Dementia or any condition affecting informed consent, including insufficient German language skills
  • Known pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during routine consultation

Diagnostic Evaluation

Duration - Same day as enrollment

Participants provide a fresh urine sample for rapid point-of-care testing and laboratory-based urine culture to evaluate bacteriuria and antibiotic susceptibility.

1 visit (in-person) for urine sample collection and testing

Long-term Monitoring

Duration - Up to 1 day

Participants are observed through data collection on clinical symptoms and management decisions during routine care.

Data collected during initial visit; no additional visits required

Trial Site Locations

Total: 2 locations

1

University Hospital Wurzburg, Department of General Practice

Würzburg, Bavaria, Germany, 97080

Actively Recruiting

2

University Hospital Jena

Jena, Thuringia, Germany, 07743

Actively Recruiting

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Research Team

P

Peter K. Kurotschka, MD

K

Kathrin Lasher, Nurse

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Psychometric properties of a self-assessment questionnaire concerning symptoms and impairment in urinary tract infections: the UTI-SIQ-8.

Ildikó Gágyor, Katrin Rentzsch, Stephanie Strube-Plaschke...

https://pubmed.ncbi.nlm.nih.gov/33589460

Bacteriuria and phenotypic antimicrobial susceptibility testing in 45 min by point-of-care Sysmex PA-100 System: first clinical evaluation.

Carles Alonso-Tarrés, Carla Benjumea Moreno, Ferran Navarro...

https://pubmed.ncbi.nlm.nih.gov/38825624