Rapid testing for bladder infections in women at general practices
Machbarkeit Und Explorative Validierung Des PA-100-AST-Systems Bei Frauen Mit Verdacht Auf Eine Unkomplizierte Harnwergsinfektion in Der Hausarztpraxis - Eine Pilotstudie
This study tests a quick urine test for bladder infections in women visiting their doctor to see if it can accurately diagnose the infection and help with treatment faster than traditional lab tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 2 sites (Würzburg, Bavaria and 1 other locations) |
| Trial ID | NCT06625268 on ClinicalTrials.gov |
What this trial studies
This study involves adult women who visit their general practitioner with symptoms indicative of a bladder infection. Participants will provide a urine sample that will be tested using the PA-100-AST system, which quickly detects bacteria responsible for urinary tract infections and assesses antibiotic susceptibility. The results from this rapid test will be compared to traditional lab culture tests to evaluate its accuracy in a general practice setting. The aim is to determine if the PA-100-AST can effectively diagnose urinary tract infections and guide treatment in a timely manner.
Who should consider this trial
Good fit: Ideal candidates for this study are adult, non-pregnant women aged 18 or older who exhibit symptoms of an uncomplicated urinary tract infection.
Not a fit: Patients with urinary catheters, severe urinary tract abnormalities, immunosuppression, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnosis and treatment of urinary tract infections in women.
How similar studies have performed: While the PA-100-AST system has shown promise in preliminary evaluations, its effectiveness in a general practice setting has not yet been established, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Age 18 or older * Clinically suspected UTI according to the general practitioner Exclusion Criteria: * Urinary catheter * Severe urinary tract abnormality (such as cancer or strictures) * Immunosuppression (such as chronic immunosuppressant use or AIDS) * Dementia or any other condition (including insufficient knowledge of the German language) that could affect informed consent * Known pregnancy
Where this trial is running
Würzburg, Bavaria and 1 other locations
- University Hospital Wurzburg, Department of General Practice — Würzburg, Bavaria, Germany (Recruiting)
- University Hospital Jena — Jena, Thuringia, Germany (Recruiting)
Study contacts
- Principal investigator: Ildikó Gágyor, MD,Professor — Wuerzburg University Hospital
- Study coordinator: Peter K. Kurotschka, MD
- Email: kurotschka_p@ukw.de
- Phone: 0049017670882259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.