Biomarkers for Ventilator-associated Pneumonia

NCT ID: NCT05117125

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia, Ventilator-Associated

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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VAP

Enrolled participants that fully meet the criteria of VAP.

Heparin-binding protein

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.

Interleukin-26

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.

Microbiome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.

Bacterial transcriptome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.

Proteome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.

Suspect VAP

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

Heparin-binding protein

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.

Interleukin-26

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.

Microbiome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.

Proteome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.

No VAP

Enrolled participants that do not develop VAP.

Heparin-binding protein

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.

Interleukin-26

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.

Microbiome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.

Proteome

Intervention Type DIAGNOSTIC_TEST

Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.

Interventions

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Heparin-binding protein

Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.

Intervention Type DIAGNOSTIC_TEST

Interleukin-26

Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.

Intervention Type DIAGNOSTIC_TEST

Microbiome

Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.

Intervention Type DIAGNOSTIC_TEST

Bacterial transcriptome

Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.

Intervention Type DIAGNOSTIC_TEST

Proteome

Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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HBP IL-26

Eligibility Criteria

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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
* Ongoing infection of the lungs at admission to the ICU.
* Severely elevated or instable intracranial pressure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Paulsson, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Fredrik Sjövall, PhD MD

Role: STUDY_CHAIR

Skane University Hospital

Locations

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Vestre Viken

Drammen, , Norway

Site Status RECRUITING

Hospital de São Francisco Xavier

Lisbon, , Portugal

Site Status RECRUITING

Skåne University Hospital, Dept. of Infectious diseases

Lund, , Sweden

Site Status RECRUITING

Skåne university Hospital, ICU

Malmo, , Sweden

Site Status RECRUITING

Karolinska University Hospital, ICU

Solna, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Norway Portugal Sweden

Central Contacts

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Magnus Paulsson, PhD MD

Role: CONTACT

+46461775431

Facility Contacts

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Karl-Erik Müller, MD PhD

Role: primary

Pedro Povoa, Professor

Role: primary

+351 21 043 1000

Magnus Paulsson, MD PhD

Role: primary

+4646175431

Fredrik Sjövall, PhD MD

Role: primary

Johan Petersson, PhD MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37234157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34103069 (View on PubMed)

Related Links

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Other Identifiers

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2021-00219

Identifier Type: -

Identifier Source: org_study_id

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