RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Performance of the novel pathogen detection assay
研究概览
简要总结
Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken.
A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed.
This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >37 weeks corrected gestation and ≤16 years old
- •Receiving mechanical ventilation
- •Commencing or already receiving antibiotic treatment for lower respiratory tract infection
排除标准
- •Survival not expected/active medical treatment expected to be withdrawn/palliative care only
结局指标
主要结局
Performance of the novel pathogen detection assay
时间窗: 3 years
Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios
次要结局
- Time to results(3 years)
- Negative cultures(3 years)
- Antibiotic therapy(3 years)
研究者
Dr Nazima Pathan
University Lecturer in Paediatric Intensive Care
Cambridge University Hospitals NHS Foundation Trust