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临床试验/NCT06918769
NCT06918769招募中不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who are suspected to have LUTs in outpatient clinic.
  • Willing to consent to participate the trial.
  • Be able to understand the nature of the study.

排除标准

  • Any suspected or known sexual transmitted diseases. (Such as gonorrhea, etc.)
  • Use of any systematic antibiotics or antiviral treatment within two weeks
  • With evidence of systematic infection including high fever, significantly increase of blood white blood cell count, etc.
  • Known or suspected allergic history/adverse drug reactions to any antibiotics
  • With previous history of multidrug resistant (MDR) bacterial infection.
  • Any medical history that indicates the need of immediate antibiotics treatment, such as chronic conditions and/or taking immunosuppressants.

研究组 & 干预措施

Control Arm

Active Comparator

Empirical antibiotics without bacterial information

干预措施: Empirical antibiotics (Drug)

Experimental Arm

Experimental

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.

干预措施: Sysmex UF-5000 system (Diagnostic Test)

结局指标

主要结局

proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment

时间窗: 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

次要结局

  • Number of participants that persist to have baseline lower tract urinary symptoms as assessed in CTCAE 4.0(1 week)
  • Number of subjects achieved urinary sterility after antibiotics treatment in confirmatory urine test(1 week)
  • Number of participants with antibiotics treatment-related adverse events as assessed by CTCAE v4.0(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yung NA

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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