Queen Mary Hospital
Hong Kong
Location status: Recruiting
NCT Number: NCT06918769
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 week
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
Time frame: 1 week
Defined as negative white blood cell in urine dipstick and no growth in urine culture. Only applies to subjects that have finished a course of antibiotics treatment under study setting.
Time frame: 1 week
The symptoms would be assessed through phone follow-up.
Time frame: 2 weeks
The symptoms would be assessed through phone follow-up.
Contact information is provided by the study sponsor or research team.
The University of Hong Kong
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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