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

Обзор

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.

Вмешательства

• Диагностический тест 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.
• Препарат Empirical antibiotics
  Empirical antibiotics per local guideline/ investigator's discretion for urinary tract infection

Первичные конечные точки

• proportion of subjects assigned with "Delay antibiotics treatment" in the intervention group that has confirmed no clinical indication for antibiotics treatment [Срок оценки: 1 week]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT06918769 · HKURO202201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗