Clinical trial NCT04840940: Presepsin Biomarker for Ventilator-associated Pneumonia Diagnosis in COVID-19 Patients
Official title: Presepsin as an Early Biomarker for Ventilator-associated Pneumonia (VAP) Diagnosis in COVID-19 Patients: a Prospective Double Blind Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Covid19
Keywords: Presepsin
VAP
Mechanical ventilation
COVID-19
Ventilator associated pneumonia
Sars-Cov-2
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring invasive mechanical ventilation for Sars-Cov 2 interstitial pneumonia

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients
timeFrame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Secondary outcomes:
measure: 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
timeFrame: Time from ICU admission to day 2
measure: 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
timeFrame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
measure: To evaluate whether plasma levels of presepsin may distinguish the presence of VAP versus VAT (ventilator-associated tracheobronchitis).
timeFrame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: SCDU Anestesia e Rianimazione, AOU San Luigi Gonzaga
state: Turin
Study officials:
affiliation: San Luigi Gonzaga Hospital
name: Pietro Caironi
role: PRINCIPAL_INVESTIGATOR
affiliation: San Luigi Gonzaga Hospital
name: Guido Bussone
role: PRINCIPAL_INVESTIGATOR
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