Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice.
Recruiting now
Conditions studied: Urinary Tract Infection (Diagnosis)
In brief
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.
Key facts
- Study ID
- NCT06625268
- Run by
- Wuerzburg University Hospital
- People needed
- 200
- Starts
- 2024-08-01
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2025-02-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female sex
- Age 18 or older
- Clinically suspected UTI according to the general practitioner
You may not qualify if…
- 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 it is running
- University Hospital Wurzburg, Department of General Practice — Würzburg, Bavaria, Germany (enrolling)
- University Hospital Jena — Jena, Thuringia, Germany (enrolling)
Full record on ClinicalTrials.gov
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