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Recruiting NCT06625268

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

Trial Parameters

Condition Urinary Tract Infection (Diagnosis)
Sponsor Wuerzburg University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-08-01
Completion 2025-04-30

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.

Eligibility 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

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