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

NCT04840940 | Unknown

• 1 other identifier: MACOSX
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Covid19

Keywords

Presepsin; VAP; Mechanical ventilation; COVID-19; Ventilator associated pneumonia; Sars-Cov-2

Outcome Measures

Primary Outcomes (1)

• To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients

  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 Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

SCDU Anestesia e Rianimazione, AOU San Luigi Gonzaga

Orbassano, Turin, 10043, Italy

RECRUITING

Related Publications (22)

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  PMID: 33211135 RESULT

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  PMID: 21839732 RESULT

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  PMID: 28875483 RESULT

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Presepsin serum level

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; COVID-19

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Pietro Caironi

  San Luigi Gonzaga Hospital

  PRINCIPAL INVESTIGATOR

• Guido Bussone

  San Luigi Gonzaga Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Caironi

CONTACT

0039 0119026510; pietro.caironi@unito.it

Pietro Caironi

CONTACT

00390119026510; pietro.caironi@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesia and Critical Care

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: December 21, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)