Early detection of ventilator-associated pneumonia in critically ill children using microbial and immune signatures.
Official title: Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children
Run by University of Cambridge · NCT07026656 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Month to 16 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Cambridge Academic / other |
| Locations | 1 site (Cambridge) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT07026656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients
This study tests whether signs of innate immune immunoparalysis in adults on ventilators are linked to developing ventilator-associated pneumonia (VAP).
-
Combined mPCR and algorithm-based therapy to optimize early antibiotics in VAP
This trial tests whether adding a broad respiratory mPCR test and a local-epidemiology algorithm helps doctors choose better initial antibiotics within 24 hours for adults with ventilator-associated pneumonia.
-
Using airway resistance changes to guide suctioning for ventilated patients
This study will test whether monitoring airway viscous resistance from ventilator waveforms can help time sputum suctioning for patients on mechanical ventilation with ARDS, AECOPD, or severe pneumonia.
-
Two Oral Care Methods for Mechanically Ventilated Adults
This trial tests whether a pediatric toothbrush or a foam swab for oral care affects oral bacteria and the risk of ventilator-associated pneumonia in adults on mechanical ventilation.
-
Aztreonam‑avibactam for MBL-producing CRE infections in hospitalized adults
This study will see if aztreonam‑avibactam helps hospitalized adults with complicated intra‑abdominal infections or hospital/ventilator‑associated pneumonia caused by MBL-producing CRE.
-
Inhaled colistin to prevent pneumonia in ventilated patients
This study is testing if inhaled colistin can help prevent pneumonia in patients on ventilators who are at high risk for infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.