Sponsor study identifier
interventional
200
1 country
1
Study Start
November 6, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2023
Actual (reported)May 7, 2024
Actual (reported)April 9, 2025
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment
The rate of unnecessary antibiotics use avoided in the intervention group. Defined as proportion of subjects assigned with "Delay antibiotics treatment" as indicated by low real-time bacterial count in urine that had negative or clinically insignificant urine culture result in one week
1 week
Number of subjects achieved urinary sterility after antibiotics treatment in confirmatory urine test
1 week
Number of participants that persist to have baseline lower tract urinary symptoms as assessed in CTCAE 4.0
1 week
Number of participants with antibiotics treatment-related adverse events as assessed by CTCAE v4.0
2 weeks
Empirical antibiotics without bacterial information
Antibiotics prescription with reference from study device. High bacterial count suggests likelihood of active UTI and indicated for antibiotics treatment; while low bacterial count suggests UTI not likely and antibiotics treatment will be delayed until urinary culture result confirms ongoing UTI.
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.
Empirical antibiotics per local guideline/ investigator's discretion for urinary tract infection
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong
First Submitted
May 7, 2024
First Posted
April 9, 2025
Study Start
November 6, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 9, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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