Clinical trial NCT05117125: Biomarkers for Ventilator-associated Pneumonia
Official title: Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia, Ventilator-Associated
Keywords: VAP
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2021-11-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General intensive care unit population.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change in HBP concentration over time
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Change in IL-26 over time
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: HBP at VAP diagnosis
timeFrame: VAP day 1 compared to No VAP day 3
measure: IL-26 at VAP diagnosis
timeFrame: VAP day 1 compared to No VAP day 3
Secondary outcomes:
measure: Diversity of microbiome
timeFrame: Day 1 and 3, and VAP day 1.
measure: Bacterial transcriptome patterns
timeFrame: VAP day 1
Other outcomes:
measure: Diagnostic certainty of VAP
timeFrame: At VAP day 1
measure: Change in CRP concentration
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Change in Differential blood cell counts
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Change in PCT concentration
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Change in lactate concentration
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Routine bacterial culture results
timeFrame: When mini-BAL is collected
measure: Change in Acute Physiology And Chronic Health Evaluation II (APACHE II)
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Change in Sequential Organ Failure Assessment (SOFA)
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
measure: Change in Simplified Acute Physiology Score III (Saps3)
timeFrame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
Locations:
city: Drammen
country: Norway
facility: Vestre Viken
city: Lisbon
country: Portugal
facility: Hospital de São Francisco Xavier
city: Lund
country: Sweden
facility: Skåne University Hospital, Dept. of Infectious diseases
city: Malmö
country: Sweden
facility: Skåne university Hospital, ICU
city: Solna
country: Sweden
facility: Karolinska University Hospital, ICU
Study officials:
affiliation: Skane University Hospital
name: Magnus Paulsson, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Fredrik Sjövall, PhD MD
role: STUDY_CHAIR
References:
citation: Paulsson M, Cardenas EI, Che KF, Brundin B, Smith M, Qvarfordt I, Linden A. TLR4-mediated release of heparin-binding protein in human airways: a co-stimulatory role for IL-26. Front Immunol. 2023 May 10;14:1178135. doi: 10.3389/fimmu.2023.1178135. eCollection 2023.
citation: Paulsson M, Thelaus L, Riesbeck K, Qvarfordt I, Smith ME, Linden A, Linder A. Heparin-binding protein in lower airway samples as a biomarker for pneumonia. Respir Res. 2021 Jun 8;22(1):174. doi: 10.1186/s12931-021-01764-2.