Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06918769

The Application of a Novel Urinalysis System (UF-5000) for Reducing Unnecessary Antibiotic Use in Clinical Suspected UTI Patients

Led by The University of Hong Kong · Updated on 2025-04-09

200

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

Sponsors

T

The University of Hong Kong

Lead Sponsor

S

Sysmex Asia Pacific

Collaborating Sponsor

AI-Summary

What this Trial Is About

Urinary tract infection (UTI) is one of the most common diseases in population while antibiotic resistant in UTI has become a critical problem in Hong Kong, that a large proportion of the bacteria in UTI resistant to commonly used anti-UTI antibiotic treatment. This is largely due to the empirical treatment (i.e. no bacteria information is available at the time of treatment) and overtreatment of antibiotics in the past decades. Some patients who did not actually have UTI were prescribed with antibiotics because they have symptoms similar to UTI. In order to avoid unnecessary use of antibiotics and therefore reduce the antibiotic resistance rates of UTI, we propose to apply a new urine sediment analyzer (UF-5000) in clinical practice for UTI which could provide quick label for potential bacteria in urine, and give more information on the possible species of the bacteria. UF-5000 is a urine sediment analyzer manufactured by Sysmex Ltd. (Japan), it is widely used in central laboratories of hospitals and private laboratories, but not commonly seen in out-patient clinic setting. UF-5000 is capable of counting the amount of bacteria present in the given urine sample and provide Gram staining\*, with results available within 5 minutes. While routine urine culture would take around 3 days. A study done by The University of Hong Kong in 2019 has shown that UF-5000 has higher accuracy than conventional dipstick, with reliable Gram staining result. It has a negative-prediction value of 96%, which means it could accurately identify the cases who had no UTI but only similar symptoms. Those cases were mostly inflammatory diseases that did not require antibiotics. This study aims to evaluate whether bacteria information provided by UF-5000 would be able to guide a precision use of antibiotic treatment and avoid unnecessary antibiotic use.

CONDITIONS

Official Title

The Application of a Novel Urinalysis System (UF-5000) for Reducing Unnecessary Antibiotic Use in Clinical Suspected UTI Patients

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients suspected to have lower urinary tract symptoms in outpatient clinics
  • Willing to consent to participate in the trial
  • Able to understand the nature of the study
Not Eligible

You will not qualify if you...

  • Suspected or known sexually transmitted diseases such as gonorrhea
  • Use of any systemic antibiotics or antiviral treatments within two weeks
  • Evidence of systemic infection including high fever or elevated white blood cell count
  • Known or suspected allergy or adverse reactions to any antibiotics
  • Previous history of multidrug resistant bacterial infection
  • Medical history requiring immediate antibiotic treatment, including chronic conditions or use of immunosuppressants

AI-Screening

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Trial Site Locations

Total: 1 location

1

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Actively Recruiting

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Research Team

R

Research Assistant

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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