Early detection of ventilator-associated pneumonia in critically ill children using microbial and immune signatures.
Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children
This project will test whether combining microbial genomic data and a child's immune-response signals can detect ventilator-associated pneumonia earlier in critically ill children on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 1 Month to 16 Years |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT07026656 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll children in the PICU who have been on invasive mechanical ventilation for at least 48 hours and collect clinical data and biological samples. Researchers will integrate microbial genomic information from respiratory samples with host immune-response signatures to identify patterns associated with VAP. These integrated signatures will be compared with clinical diagnoses, culture results, and outcomes such as duration of ventilation and length of PICU stay. The aim is to identify pre-clinical markers that could signal VAP before conventional criteria or cultures become definitive.
Who should consider this trial
Good fit: Children admitted to the PICU who have required invasive mechanical ventilation for at least 48 hours and who are not immunocompromised, do not have a tracheostomy, have not received a full course of systemic antibiotics in the past six weeks, are not on a palliative pathway, and do not have known or suspected tuberculosis.
Not a fit: Patients who are immunocompromised, have an existing tracheostomy, received a full course of systemic antibiotics in the prior six weeks, have known or suspected TB, or are imminently dying/on a palliative pathway are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the approach could enable earlier, more accurate diagnosis of VAP, helping reduce unnecessary antibiotics and shorten ventilation time and PICU stays.
How similar studies have performed: Related work combining pathogen sequencing and host-response biomarkers has shown promise in adults and some pediatric respiratory infections, but applying these integrated signatures specifically to VAP in critically ill children remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PICU Admission * Requires 48 Hours Of Mechanical Ventilation Exclusion Criteria: * Imminent death or palliative care pathway planned * Existing tracheostomy at time of admission * Known immunocompromised patient * Patient received a full course of systemic antimicrobials in the previous 6 weeks. * Known or suspected tuberculosis (TB).
Where this trial is running
Cambridge
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nazima Pathan, FRCPCH PhD — Department of Paediatrics, University of Cambridge
- Study coordinator: Nazima Pathan, FRCPCH PhD
- Email: np409@medschl.cam.ac.uk
- Phone: +441223 805000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.