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COMPLETED
NCT06918769
NA

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

Urinary tract infection (UTI) is one of the most common diseases in the population, while antibiotic resistance in UTI has become a critical problem in Hong Kong, with a large proportion of bacteria causing UTI resistant to commonly used anti-UTI antibiotic treatments. This resistance is largely due to empirical treatment (i.e. no bacterial information is available at the time of treatment) and antibiotic overtreatment over the past decades. Some patients without UTI were prescribed antibiotics because of symptoms similar to UTI. To avoid unnecessary antibiotic use and therefore reduce antibiotic resistance rates in UTI, the investigators propose to apply a new urine sediment analyzer (UF-5000) in clinical practice for UTI. The analyzer could provide rapid identification of potential bacteria in urine and more information on possible bacterial species. UF-5000 is a urine sediment analyzer manufactured by Sysmex Ltd. (Japan). The analyzer is widely used in hospital central laboratories and private laboratories but is not commonly seen in outpatient clinic settings. UF-5000 is capable of counting bacteria present in a urine sample and providing Gram staining results within 5 minutes, while routine urine culture takes around 3 days. A study conducted by The University of Hong Kong in 2019 showed that UF-5000 has higher accuracy than conventional dipstick testing, with reliable Gram staining results. The analyzer has a negative predictive value of 96%, indicating a high likelihood that a negative result corresponds to the absence of UTI. Cases with symptoms similar to UTI were mostly inflammatory diseases without a need for antibiotics. This study aims to evaluate whether bacterial information provided by UF-5000 can guide precise antibiotic treatment and avoid unnecessary antibiotic use.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2023-11-06

Completion Date

2026-02-28

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Sysmex UF-5000 system

Provide real time bacterial count in urine samples and Gram-staining results. High bacterial count suggests likelihood of active UTI and indicated for antibiotics treatment; while low bacterial count suggests UTI not likely.

DRUG

Empirical antibiotics

Empirical antibiotics, including amoxicillin/clavulanate (Augmentin), cefuroxime, ciprofloxacin, levofloxacin, and nitrofurantoin, per local guidelines and/or the investigator's discretion for urinary tract infection.

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong