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

NCT06625268 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

  • Urinary Tract Infection (Diagnosis)

Sponsors & Collaborators

  • Jena University Hospital

    collaborator OTHER

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Ildikó Gágyor, MD,Professor · University Hospital Wuerzburg

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06625268 on ClinicalTrials.gov