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NCT Number: NCT07545096

Host Response and Pathogen Genomics in Childhood Respiratory Infection

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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Imminent death or palliative care pathway planned

Treatment and study plan

Non-Interventional Study

Other

No intervention

Primary outcomes

  1. Protein biomarker in the bronchoalveolar lavage fluid

    Time frame: Day 1

  2. Host transcriptome detectable in bronchoalveolar fluid

    Time frame: Day 1

  3. Cellular host response in bronchoalveolar fluid

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study title

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

Acronym: INTERACT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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