Presepsin Biomarker for Ventilator-associated Pneumonia Diagnosis in COVID-19 Patients

April 13, 2021 updated by: Pietro Caironi, San Luigi Gonzaga Hospital

Presepsin as an Early Biomarker for Ventilator-associated Pneumonia (VAP) Diagnosis in COVID-19 Patients: a Prospective Double Blind Observational Study

This study is observational and double blind. It evaluates the validity of presepsin (a serum biomarker of bacterial infections) as early biomarker of Ventilator Associated Pneumonia. It will be measured at day 0 (ICU admission) and every 48 hours in every patient with Sars-Cov 2 interstitial pneumonia requiring invasive mechanical ventilation (see inclusion ad exclusion criteria) until Day 30, ICU discharge or ICU death. There will be no change in clinical practice and in pneumonia diagnosis. We will examine how the elevation of presepsin level could be an early marker of ventilator associated pneumonia or a marker of bacterial pneumonia at ICU admission, before the microbiological results or clinical diagnosis.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will be a single center, double blind observational study.

Measurements of presepsin blood level will be performed in all patients with interstitial Sars-Cov-2 pneumonia admitted to ICU, at the time of the start of invasive mechanical ventilation and every 48 hours for the first 30 days of ICU stay. Surveillance respiratory samples (endotracheal aspiration) will be performed according to clinical practice (at ICU admission and every Mondays and Thursdays in all patients undergoing invasive mechanical ventilation).

In all patients admitted to ICU with invasive mechanically ventilation, a bronchoalveolar lavage with rapid microbiological method (film array for the research of the main respiratory pathogens) will be performed, according to common clinical practice.

VAP diagnosis will be made based upon the evidence of new lung infiltrates (chest radiography or chest computed tomography) in association with the presence of a pathogen isolated in the non-invasive respiratory sample with semi-quantitative method, according to IDSA and American Thoracic Society guidelines, as well as the presence of other sign of infection (fever, leukocytosis, worsening of oxygenation).

The attending physician in charge of the patient enrolled, clinically making the diagnosis of VAP will be blinded of presepsin levels. As a consequence, during the study period, no variation of the clinical practice applied will be performed, and no influence on the care provided to patients included will be determined by the measurement of plasma presepsin.

In the current study, we aim to answer to the following questions:

  • Does a high level of plasma presepsin in patients with a Sars Cov 2 interstitial pneumonia at the time of ICU admission predict the presence of a bacterial respiratory co-infection?
  • Do presepsin levels early predict the occurrence of VAP in patients with COVID-19 disease?
  • Does such variation become evident at the time of VAC, therefore anticipating the diagnosis of IVAC? The latter issue might be particularly important in order to commence antibiotic therapy earlier than the diagnosis of IVAC.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Turin
      • Orbassano, Turin, Italy, 10043
        • Recruiting
        • SCDU Anestesia e Rianimazione, AOU San Luigi Gonzaga
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring invasive mechanical ventilation for Sars-Cov 2 interstitial pneumonia

Description

Inclusion Criteria:

  • ICU patients with Sars Cov 2 interstitial pneumonia requiring invasive mechanical ventilation

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy
  • Chronic renal failure stage III or more
  • End stage liver disease
  • Patients already present in the ICU at the beginning of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients
Time Frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Circulating presepsin levels every other day (from day 0 to day 30)
Time from ICU admission to day 30 or to ICU discharge or to ICU death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate whether presepsin level can predict the presence of a bacterial respiratory co-infection at the time of ICU admission in patient with Sars-CoV-2 interstitial pneumonia
Time Frame: Time from ICU admission to day 2
Circulating presepsin levels every other day (from day 0 to day 2)
Time from ICU admission to day 2
To evaluate the role of circulating presepsin time course during the treatment of VAP as a clinical marker of the adequacy of the antibiotic therapy applied
Time Frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Circulating presepsin levels every other day (from day 0 to day 30)
Time from ICU admission to day 30 or to ICU discharge or to ICU death
To evaluate whether plasma levels of presepsin may distinguish the presence of VAP versus VAT (ventilator-associated tracheobronchitis).
Time Frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Circulating presepsin levels every other day (from day 0 to day 30)
Time from ICU admission to day 30 or to ICU discharge or to ICU death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Luigi Gonzaga Hospital

Investigators

  • Principal Investigator: Pietro Caironi, San Luigi Gonzaga Hospital
  • Principal Investigator: Guido Bussone, San Luigi Gonzaga Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Anticipated)

December 21, 2021

Study Completion (Anticipated)

December 21, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MACOSX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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