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

NCT06625268 | Recruiting

• 1 other identifier: 2024-3379-BO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Tract Infection (Diagnosis)

Keywords

urinary tract infection; women; general practice; diagnosis; primary care; point-of-care test

Outcome Measures

Primary Outcomes (6)

• Sensitivity

  Sensitivity of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)

  On the 1 day of inclusion

• Specificity

  Specificity of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)

  On the 1 day of inclusion

• Positive predictive value

  Positive predictive value of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)

  On the 1 day of inclusion

• Negative predictive value

  Negative predictive value of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)

  On the 1 day of inclusion

• Positive likelihood ratio

  Positive likelihood ratio of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)

  On the 1 day of inclusion

• Negative likelihood ratio

  Negative likelihood ratio of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)

  On the 1 day of inclusion

Other Outcomes (1)

• Agreement of test results for antibiotic susceptibility

  On the 1 day of inclusion

Study Arms (1)

Women with suspected UTI

Adult women with suspected uncomplicated urinary tract infections

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutively enrolled adult non-pregnant women with a suspected uncomplicated UTI (uncomplicated is defined according to German guidelines/usual care as having no symptoms or signs of systemic illness, such as fever).

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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Jena University Hospital: collaborator

Study Sites (2)

University Hospital Wurzburg, Department of General Practice

Würzburg, Bavaria, 97080, Germany

RECRUITING

University Hospital Jena

Jena, Thuringia, 07743, Germany

RECRUITING

Related Publications (2)

• Gagyor I, Rentzsch K, Strube-Plaschke S, Himmel W. Psychometric properties of a self-assessment questionnaire concerning symptoms and impairment in urinary tract infections: the UTI-SIQ-8. BMJ Open. 2021 Feb 15;11(2):e043328. doi: 10.1136/bmjopen-2020-043328.

  PMID: 33589460 BACKGROUND

• Alonso-Tarres C, Benjumea Moreno C, Navarro F, Habison AC, Gonzalez-Bertran E, Blanco F, Borras J, Garrigo M, Saker J. Bacteriuria and phenotypic antimicrobial susceptibility testing in 45 min by point-of-care Sysmex PA-100 System: first clinical evaluation. Eur J Clin Microbiol Infect Dis. 2024 Aug;43(8):1533-1543. doi: 10.1007/s10096-024-04862-3. Epub 2024 Jun 3.

  PMID: 38825624 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ildikó Gágyor, MD,Professor

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter K. Kurotschka, MD

CONTACT

0049017670882259; kurotschka_p@ukw.de

Kathrin Lasher, Nurse

CONTACT

lasher_k@ukw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 3, 2024
• Study Start: August 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)