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临床试验/NCT07545096
NCT07545096尚未招募不适用

Observational Study Integrating Host Response Biomarkers With Pathogen Genomics for Precision Diagnosis in Children With Severe Respiratory Infection

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Protein biomarker in the bronchoalveolar lavage fluid

研究概览

简要总结

A major challenge in children's infections is that it is difficult to work out which bug is making them unwell. Tests can find the bugs that are present though there can be more than one. Some bugs may just be bystanders and not actually making the child sick. Children still receive antibiotics because it is not always clear that they don't need them.

This project explores whether measuring how the body is reacting to the bugs gives precise information about which bug is actually making them sick. It will investigate children in intensive care who are suspected of having a chest infection.

This study uses a novel technology called "metagenomics" to detect any bacteria or viruses in the lung. Alongside this, investigators will measure how the lungs respond to the bugs through further tests of cells and proteins collected from the lung fluid. This fluid will be tested to see if the response is due to bacteria or viruses.

Collecting lung fluid samples requires that children are sedated and intubated, having a breathing tube in place. This means that only children intubated in intensive care are eligible. Extra samples of lung fluid and blood will be collected when being taken for routine clinical care.

If these tests work, they have the potential to give rapid and accurate information about what type of infection is taking place in the lung. This means the correct antibiotics can be given to children who need them and avoid the harms of giving them to children who do not. This can reduce cost, improve patient outcomes and help limit the development of antibiotic resistance.

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
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Admission to PICU and intubated and ventilated (including via tracheostomy)
  • Possible or proven lower respiratory tract infection

排除标准

  • Imminent death or palliative care pathway planned

结局指标

主要结局

Protein biomarker in the bronchoalveolar lavage fluid

时间窗: Day 1

Host transcriptome detectable in bronchoalveolar fluid

时间窗: Day 1

Cellular host response in bronchoalveolar fluid

时间窗: Day 1

次要结局

未报告次要终点

研究者

发起方
Guy's and St Thomas' NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

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