'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of individual urine biomarkers
研究概览
简要总结
The goal of this study is to improve the diagnosis of urinary tract infections (UTI) in older people (≥65 years). The main research questions are:
Research questions
- What is the optimal cut-off for each individual biomarker NGAL,IL-6,AZU,TIMP2 and CXCL9 and associated, sensitivity, specificity, negative and positive predictive value.
- sensitivity, specificity, negative and positive predictive value of a urine leukocyte count cut-off of 200 cells/microL (validation)
- What is the optimal combination of biomarkers for UTI diagnosis in older patients
- As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1) duration of symptoms 2) complications, 3) recurrence of UTI within 2 months, and length of hospital stay. Next to this, the performance of the astrego PA100 will be validated in diagnosing bacteriuria.
Participants will:
- be asked to provide a urine sample once at the beginning of the study
- be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks
- have their vital parameters (temperature and blood pressure) measured once at the beginning of the study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of individual urine biomarkers
时间窗: At Baseline
Area under the receiver operating characteristic curve (AUC) for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Diagnostic accuracy of urine biomarker panel
时间窗: At Baseline
The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers.
Diagnostic accuracy of leukocytes in urine
时间窗: At Baseline
Negative and positive predictive value in percentages for the cut-off of 200 leukocytes/microL in urine
次要结局
- Duration of symptoms(1 week after inclusion, if not yet resolved again at 8 weeks)
- Length of hospital stay(1 week after inclusion, if not yet resolved again at 8 weeks)
- Complications(1 week after inclusion, if not yet resolved again at 8 weeks)
- Recurrence of UTI <2 months(8 weeks after inclusion)
- Diagnostic performance of PA100 in detecting bacteruria(baseline)
研究者
Nora El Moussaoui
drs. N. El Moussaoui
Leiden University Medical Center