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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.

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated February 17, 2025 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jan 31, 2025 to Apr 30, 2025
    • Site details revised at 1 of 2 sites
    • Study description shortened, about 2 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06625268
Lead Sponsor Wuerzburg University Hospital
Collaborators: Jena University Hospital
Conditions
(from sponsor)		 Urinary Tract Infection (Diagnosis)
Related terms Disease, Urinary Tract Infections
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov