Evaluating biomarkers for pneumonia in ventilated patients
Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
This study is testing if certain biological markers in the body can help doctors better diagnose and predict pneumonia in patients on ventilators in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 5 sites (Drammen and 4 other locations) |
| Trial ID | NCT05117125 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess various peptide biomarkers, microbiome variations, and bacterial transcriptome patterns to identify prognostic and diagnostic indicators for ventilator-associated pneumonia (VAP). Patients admitted to intensive care units who have been intubated within the last 24 hours and are expected to be mechanically ventilated for at least 48 hours will be monitored. The study will analyze the relationship between these biomarkers and the development of VAP, potentially leading to improved diagnostic methods. The research will involve collaboration between multiple hospitals and institutions to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates for this study are patients admitted to an intensive care unit who have been intubated within the last 24 hours and are expected to require mechanical ventilation for at least 48 hours.
Not a fit: Patients with severe coagulopathy, ongoing lung infections at ICU admission, or significantly elevated intracranial pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnosis of ventilator-associated pneumonia, improving patient outcomes.
How similar studies have performed: While the approach of using biomarkers for diagnosing pneumonia is not entirely novel, the specific focus on VAP and the combination of microbiome and transcriptome analysis represents a potentially innovative angle that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admission to an intensive care unit * Intubation within last 24 hours * Anticipated mechanical ventilation of at least 48 hours Exclusion Criteria: * FiO2 above 70% or PEEP above 15 * Severe coagulopathy (spontaneous PK(INR) \>1.8 or thrombocytes \<50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors/NOAC is not an exclusion criteria. If higher doses of these substances are administered, the responsible clinician should be consulted before sample collection. * Ongoing infection of the lungs at admission to the ICU. * Severely elevated or instable intracranial pressure.
Where this trial is running
Drammen and 4 other locations
- Vestre Viken — Drammen, Norway (Recruiting)
- Hospital de São Francisco Xavier — Lisbon, Portugal (Recruiting)
- Skåne University Hospital, Dept. of Infectious diseases — Lund, Sweden (Recruiting)
- Skåne university Hospital, ICU — Malmö, Sweden (Recruiting)
- Karolinska University Hospital, ICU — Solna, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Magnus Paulsson, PhD MD — Skane University Hospital
- Study coordinator: Magnus Paulsson, PhD MD
- Email: magnus.paulsson@med.lu.se
- Phone: +46461775431
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.