NCT06625268 Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice.
| NCT ID | NCT06625268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wuerzburg University Hospital |
| Condition | Urinary Tract Infection (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-08-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Ildikó Gágyor, MD,Professor
PRINCIPAL INVESTIGATOR
Wuerzburg University Hospital
Frequently Asked Questions
Who can join the NCT06625268 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Tract Infection (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06625268 currently recruiting?
Yes, NCT06625268 is actively recruiting participants. Contact the research team at kurotschka_p@ukw.de for enrollment information.
Where is the NCT06625268 trial being conducted?
This trial is being conducted at Würzburg, Germany, Jena, Germany.
Who is sponsoring the NCT06625268 clinical trial?
NCT06625268 is sponsored by Wuerzburg University Hospital. The principal investigator is Ildikó Gágyor, MD,Professor at Wuerzburg University Hospital. The trial plans to enroll 200 participants.