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

• Conditions: Ventilator Associated Pneumonia; Covid19

• Registration Number: NCT04840940
• Lead Sponsor: San Luigi Gonzaga Hospital

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.

Study Timeline

• Study Start: 2020-12-21
• Status Verified: 2021-04
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-19
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients	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)

Secondary Outcome Measures

Name	Time	Method
To evaluate whether plasma levels of presepsin may distinguish the presence of VAP versus VAT (ventilator-associated tracheobronchitis).	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)
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 from ICU admission to day 2	Circulating presepsin levels every other day (from day 0 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 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)

Trial Locations

Locations (1)

SCDU Anestesia e Rianimazione, AOU San Luigi Gonzaga; 🇮🇹 Orbassano, Turin, Italy