Pneumonia, Ventilator-AssociatedVAPmarkersNCT05117125
Biomarkers for Ventilator-associated Pneumonia
An observational study of Pneumonia, Ventilator-Associated, run by Region Skane at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Heparin-binding protein, Interleukin-26 and Microbiome
- How many people
- 1,000 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 Oct 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General intensive care unit population.
Who may be able to join
- Admission to an intensive care unit
- Intubation within last 24 hours
- Anticipated mechanical ventilation of at least 48 hours
Who cannot join
- 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 locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Sweden3 sites, 3 recruiting
- Recruiting
Skåne University Hospital, Dept. of Infectious diseases
Lund
Magnus Paulsson, MD PhD, +4646175431, magnus.paulsson@med.lu.se
- Recruiting
Skåne university Hospital, ICU
Malmö
Fredrik Sjövall, PhD MD
- Not yet recruiting
Karolinska University Hospital, ICU
Solna
Johan Petersson, PhD MD
Norway1 site, 1 recruiting
- Recruiting
Vestre Viken
Drammen, 3004
Karl-Erik Müller, MD PhD, +4703525, kamull@vestreviken.no
Portugal1 site, 1 recruiting
- Recruiting
Hospital de São Francisco Xavier
Lisbon
Pedro Povoa, Professor, +351 21 043 1000, pedro.povoa@nms.unl.pt
About this study
Official title: Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
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.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Heparin-binding protein, Interleukin-26, Microbiome, Bacterial transcriptome, Proteome
- Keywords
- VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin-binding proteinDiagnostic test
Also called HBP
Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
Interleukin-26Diagnostic test
Also called IL-26
Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
MicrobiomeDiagnostic test
Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
Bacterial transcriptomeDiagnostic test
Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.
ProteomeDiagnostic test
Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.
| Study group | Role | What they receive |
|---|---|---|
| VAP | Enrolled participants that fully meet the criteria of VAP. Receives: Diagnostic Test: Heparin-binding protein; Diagnostic Test: Interleukin-26; Diagnostic Test: Microbiome; Diagnostic Test: Bacterial transcriptome; Diagnostic Test: Proteome | |
| Suspect VAP | Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP. Receives: Diagnostic Test: Heparin-binding protein; Diagnostic Test: Interleukin-26; Diagnostic Test: Microbiome; Diagnostic Test: Proteome | |
| No VAP | Enrolled participants that do not develop VAP. Receives: Diagnostic Test: Heparin-binding protein; Diagnostic Test: Interleukin-26; Diagnostic Test: Microbiome; Diagnostic Test: Proteome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HBP concentration over time
Change in concentration (ng/ml) compared to baseline.
Measured: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
Change in IL-26 over time
Change in concentration (ng/ml) compared to baseline.
Measured: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
HBP at VAP diagnosis
Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
Measured: VAP day 1 compared to No VAP day 3
IL-26 at VAP diagnosis
Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
Measured: VAP day 1 compared to No VAP day 3
Secondary outcomes (2)
Diversity of microbiome
Changes in alpha and beta diversity as prognostic biomarker for VAP. Cases that develop VAP are compared to cases with no VAP.
Measured: Day 1 and 3, and VAP day 1.
Bacterial transcriptome patterns
Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.
Measured: VAP day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Magnus Paulsson, PhD MD, Principal investigator, Skane University HospitalFredrik Sjövall, PhD MD, Study chair, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117125
- Sponsor's protocol ID
- 2021-00219
- Acronym
- VAPmarkers
- Status last verified
- Jun 2026
- First submitted
- 15 Oct 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in published articles will be shared with investigators after deidentification upon request.
Publications
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.
PubMed 37234157Paulsson 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.
PubMed 34103069
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT05117125
- Acronym / sponsor ID
- VAPmarkers / 2021-00219
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- VAP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VAP | – | Diagnostic Test: Heparin-binding protein, Diagnostic Test: Interleukin-26, Diagnostic Test: Microbiome, Diagnostic Test: Bacterial transcriptome, Diagnostic Test: ProteomeEnrolled participants that fully meet the criteria of VAP. |
| Suspect VAP | – | Diagnostic Test: Heparin-binding protein, Diagnostic Test: Interleukin-26, Diagnostic Test: Microbiome, Diagnostic Test: ProteomeEnrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP. |
| No VAP | – | Diagnostic Test: Heparin-binding protein, Diagnostic Test: Interleukin-26, Diagnostic Test: Microbiome, Diagnostic Test: ProteomeEnrolled participants that do not develop VAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General intensive care unit population.
Key inclusion criteria (3 listed)
- Admission to an intensive care unit
- Intubation within last 24 hours
- Anticipated mechanical ventilation of at least 48 hours
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin-binding proteinAlso: HBPEvaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP. | Diagnostic test | No VAP, Suspect VAP, VAP |
| Interleukin-26Also: IL-26Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP. | Diagnostic test | No VAP, Suspect VAP, VAP |
| MicrobiomeEvaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP. | Diagnostic test | No VAP, Suspect VAP, VAP |
| Bacterial transcriptomeEvaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP. | Diagnostic test | VAP |
| ProteomeEvaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP. | Diagnostic test | No VAP, Suspect VAP, VAP |
Primary outcome
Change in HBP concentration over time
Time frame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
Change in concentration (ng/ml) compared to baseline.
Change in IL-26 over time
Time frame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
Change in concentration (ng/ml) compared to baseline.
HBP at VAP diagnosis
Time frame: VAP day 1 compared to No VAP day 3
Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
IL-26 at VAP diagnosis
Time frame: VAP day 1 compared to No VAP day 3
Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
2 secondary outcomes
Diversity of microbiome
Time frame: Day 1 and 3, and VAP day 1.
Bacterial transcriptome patterns
Time frame: VAP day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 37234157Paulsson 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.
- Background: PubMed 34103069Paulsson 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in published articles will be shared with investigators after deidentification upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus Paulsson, PhD MD principal investigator
Skane University Hospital
Fredrik Sjövall, PhD MD study chair
Skane University Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated, run by Region Skane at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Norway, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Paulsson, PhD MD (+46461775431, magnus.paulsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HBP concentration over time (time frame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117125, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.