Urine COLLECTion and Novel UTI Biomarkers in Children and Older Adults (COLLECT - UTI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity and area under the receiver operating characteristic curve (AUC) of urinary host biomarkers for paediatric UTI
研究概览
简要总结
Suspected urinary tract infection (UTI) is a common driver of antibiotic prescribing and hospital admission, yet accurate diagnosis remains challenging. Young children and older adults often present without localising urinary symptoms, and current urine tests perform poorly in these groups. In non-toilet-trained children, non-invasive urine collection methods are associated with high contamination rates. In older adults, asymptomatic bacteriuria (ASB) is common and complicates interpretation of urine culture results. As UTIs are a leading cause of sepsis in both groups, this diagnostic uncertainty contributes to overdiagnosis and overtreatment. COLLECT-UTI aims to improve UTI diagnostics by evaluating novel urinary host and bacterial markers to distinguish true UTI from contaminated samples in children and from ASB in older adults.
The COLLECT-UTI study is a prospective observational study of children under 5 years of age and adults aged 65 years and over undergoing testing for suspected urinary tract infection (UTI). The study will recruit approximately 230 participants in total. Clinical features, laboratory results and 14-day outcomes will be recorded on an electronic case report form (CRF) and REDCap database. Residual urine samples collected during routine clinical care will be used to investigate novel urinary host biomarkers and bacterial markers to improve the diagnosis of UTI.
详细描述
Background:
Urinary tract infection (UTI) is one of the most common bacterial infections requiring medical assessment in young children and older adults. Accurate diagnosis is particularly challenging at the extremes of age, where patients frequently present with non-specific symptoms and current urine diagnostic tests perform poorly. In young children, contamination of urine samples collected using non-invasive methods often results in false-positive urine cultures, while in older adults the high prevalence of asymptomatic bacteriuria (ASB) makes it difficult to distinguish bacterial colonisation from true infection. These diagnostic limitations contribute to unnecessary antibiotic prescribing, avoidable hospital admissions and increased antimicrobial resistance. This study aims to evaluate novel urinary host and bacterial biomarkers to improve the diagnosis of UTI by distinguishing true infection from contamination in children and from ASB in older adults.
Objectives:
Primary Objectives:
- Determine the diagnostic accuracy (sensitivity, specificity and AUC) of urinary host biomarkers for diagnosing paediatric UTI across different urine collection methods.
- To characterise the molecular features of urine samples from children with different microbiological classifications of urinary tract infection.
- To characterise the molecular features of urine samples from older adults with symptomatic urinary tract infection and asymptomatic bacteriuria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 5 years of age who are not toilet trained.
- •Urine dipstick positive for nitrates or leukocytes (including trace).
- •Residual urine sample remaining following completion of all routine clinical urine testing.
- •Older Adults:
- •Adults aged 65 years and over.
- •Urine dipstick positive for nitrates or leukocytes (including trace).
- •Residual urine sample remaining following completion of all routine clinical urine testing.
排除标准
- •Consent declined.
- •Inability to obtain informed consent.
- •Antibiotic treatment within the previous 48 hours for acute infection.
结局指标
主要结局
Sensitivity, specificity and area under the receiver operating characteristic curve (AUC) of urinary host biomarkers for paediatric UTI
时间窗: 14 days from attendance
The diagnostic performance of urinary host biomarkers for paediatric UTI will be evaluated against the reference standard urine culture. Sensitivity, specificity and area under the receiver operating characteristic curve (AUC) will be calculated, with diagnostic performance also compared across urine collection methods.
Molecular characterisation of paediatric urine samples
时间窗: 14 days from attendance
Molecular analyses will be performed to identify biological signatures associated with different urine sample classifications, including confirmed UTI, contaminated samples and, where available, healthy controls.
Molecular characterisation of urine samples from older adults
时间窗: 14 days from attendance
Molecular analyses will be performed to identify biological signatures associated with symptomatic UTI and asymptomatic bacteriuria.
次要结局
未报告次要终点
研究者
Thomas Waterfield
PI
Queen's University, Belfast