Biomarkers for Ventilator-associated Pneumonia (VAPmarkers)

Region Skane

Status: Enrolling

Conditions: Pneumonia, Ventilator-Associated

Treatments: Diagnostic Test: Microbiome; Diagnostic Test: Heparin-binding protein; Diagnostic Test: Proteome; Diagnostic Test: Interleukin-26; Diagnostic Test: Bacterial transcriptome

Study type: Observational

Funder types: Other

Identifiers

NCT05117125

2021-00219

Details and patient eligibility

About

The purpose of this study is to evaluate different peptide biomarkers, variations in the microbiome and patterns in the bacterial transcriptome as prognostic or diagnostic biomarkers of VAP.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

VAP

Description:

Enrolled participants that fully meet the criteria of VAP.

Treatment:

Diagnostic Test: Bacterial transcriptome

Diagnostic Test: Interleukin-26

Diagnostic Test: Proteome

Diagnostic Test: Microbiome

Diagnostic Test: Heparin-binding protein

Suspect VAP

Description:

Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP.

Treatment:

Diagnostic Test: Interleukin-26

Diagnostic Test: Proteome

Diagnostic Test: Microbiome

Diagnostic Test: Heparin-binding protein

No VAP

Description:

Enrolled participants that do not develop VAP.

Treatment:

Diagnostic Test: Interleukin-26

Diagnostic Test: Proteome

Diagnostic Test: Microbiome

Diagnostic Test: Heparin-binding protein