Machbarkeit Und Explorative Validierung Des PA-100-AST-Systems Bei Frauen Mit Verdacht Auf Eine Unkomplizierte Harnwergsinfektion in Der Hausarztpraxis - Eine Pilotstudie
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
In this study, adult women presenting at their general practitioner with a likely bladder infection (with symptoms like a burning sensation when urinating, pain in the lower abdomen, and frequent or urgent need to urinate) will be invited. After informed consent, women provide a urine sample, which is tested using a new system called the PA-100-AST (from the manufacturer Sysmex). This point-of-care test showed first evidence to be able to quickly detect the presence of bacteria commonly responsible for bladder infections. If bacteria are found, the test also checks which antibiotics may work best to treat the infection. Additionally, a sample of the urine is sent to a lab for a traditional culture test, which is considered the most accurate method. The goal of this study is to compare the accuracy of the PA-100-AST system to the lab-based test to see how well it works in general practice.
详细描述
The PA-100-AST urine analyzer from Sysmex is a rapid point-of-care test currently registered as a medicinal product. The system identifies bacteriuria (≥ 50,000 CFU/mL) and reports antibiotic susceptibility results as susceptible (S), susceptible with increased exposure (I), resistant (R), or not applicable (NA) for amoxicillin/clavulanic acid, ciprofloxacin, fosfomycin, nitrofurantoin, and trimethoprim, based on EUCAST standards. Although the system detects bacteriuria, it does not inform the user of the specific bacterial species involved, providing only a positive or negative result.
The PA-100 cartridge is designed to detect common uropathogens: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis, and Staphylococcus saprophyticus. A proprietary internal algorithm classifies bacteria into one of three groups (Enterobacterales, Staphylococcus, or Enterococcus) and applies appropriate EUCAST breakpoints.
This product is authorized and CE-marked in the European Union for point-of-care use in women with suspected uncomplicated urinary tract infections (UTIs).
However, the PA-100-AST system has not yet been evaluated in a general practice setting. The goal of this study is to compare the results of the Sysmex PA-100-AST with laboratory-based urine culture in a consecutive sample of adult women recruited from general practices.
Recruitment. Adult, non-pregnant women with symptoms suggestive of uncomplicated UTI will be recruited consecutively and prospectively during routine consultations in at least four general practices across two German practice-based research networks (Bavaria and Thuringia). Informed consent will be obtained from all participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age 18 or older
- •Clinically suspected UTI according to the general practitioner
排除标准
- •Urinary catheter
- •Severe urinary tract abnormality (such as cancer or strictures)
- •Immunosuppression (such as chronic immunosuppressant use or AIDS)
- •Dementia or any other condition (including insufficient knowledge of the German language) that could affect informed consent
- •Known pregnancy
结局指标
主要结局
Sensitivity
时间窗: On the 1 day of inclusion
Sensitivity of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Specificity
时间窗: On the 1 day of inclusion
Specificity of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Positive predictive value
时间窗: On the 1 day of inclusion
Positive predictive value of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Negative predictive value
时间窗: On the 1 day of inclusion
Negative predictive value of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Positive likelihood ratio
时间窗: On the 1 day of inclusion
Positive likelihood ratio of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Negative likelihood ratio
时间窗: On the 1 day of inclusion
Negative likelihood ratio of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
次要结局
未报告次要终点