Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients (SUPER-HI)

June 29, 2022 updated by: Jan Malaska, Brno University Hospital

Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients (SUPER-HI) - Prospective Observational Study

Patients suffering from COVID-19 (Coronavirus Disease 2019) pneumonia are prone to bacterial and mycotic superinfection. According to existing evidence, the prevalence of superinfection is about 8% to 14% (95% CI 5-26%). However, the percentage of patients treated for superinfection is as high as 80%. There can be multiple reasons for this difference.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The inflammatory markers, such as C-reactive protein (CRP), procalcitonin (PCT), presepsin (PSP), interleukin-6 (IL-6) frequently used as diagnostic tools in COVID-19 (Coronavirus Disease 2019), are usually increased in these patients. This increase is a result of activation of systemic inflammatory cascade, part of COVID-19 pathophysiologic pathway. This can escalate to state known as COVID-19 associated hyperinflamation (COV-HI). In addition, current diagnostic tools for diagnosing HAP/VAP (hospital-acquired pneumonia and ventilator-associated pneumonia) are often limited in patients with COVID-19 pneumonia. The current method of choice for superinfection diagnosing is BAL (Bronchoalveolar Lavage). The COV-HI phenotype (COV-HI: CRP > 150 mg/L, or doubling within 24 h from greater than 50 mg/L, or ferritin concentration > 1500 ug/L) is associated with significantly worse course of illness and higher mortality rates. These inflammatory markers may be used preferentially as prognostication tools, not bacterial superinfection markers. The intention of this project is to investigate the role of currently used inflammatory biomarkers. Or eventually, to discover new parameters associated with superinfection proven by BAL.

Study Type

Observational

Enrollment (Anticipated)

300

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 Locations

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 diagnostics:

PCR test from nasopharyngeal swab or tracheal aspirate plus Chest X-ray/Computer tomography signs of pneumonia

Description

Inclusion Criteria:

  1. admission on ICU
  2. age more than 18 years
  3. COVID-19 pneumonia criteria fulfilled

Exclusion Criteria: none

-

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with COVID-19 pneumonia without superinfection
Patients with confirmed COVID-19 pneumonia not fulfilling criteria for diagnosis HAP/VAP (International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia )
Diagnostic test: Inflammatory markers sampling

Laboratory sampling:

Haematology: complete blood count, reticulocytes, IFP, PT, aPTT, fibrinogen, D-dimer Biochemical profile: urea, creatinine, bilirubin, ALT, AST, GGT, CK, LD, ferritin, troponin Inflammation markers IL-6, PCT (procalcitonin), CRP (C-reactive protein), PSP (presepsin)

BALF (bronchoalveolar lavage fluid) processing protocol:

  1. microbiology: microscopic examination, standard cultivation test
  2. biochemistry: albumin, total protein
  3. Pathology: cytology
  4. PCR:

a. Multiplex PCR b. SARS-CoV-2 RNA load
Patients with COVID-19 pneumonia with superinfection
Patients with confirmed COVID-19 pneumonia fulfilling criteria for diagnosis HAP/VAP (International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia )
Diagnostic test: Inflammatory markers sampling

Laboratory sampling:

Haematology: complete blood count, reticulocytes, IFP, PT, aPTT, fibrinogen, D-dimer Biochemical profile: urea, creatinine, bilirubin, ALT, AST, GGT, CK, LD, ferritin, troponin Inflammation markers IL-6, PCT (procalcitonin), CRP (C-reactive protein), PSP (presepsin)

BALF (bronchoalveolar lavage fluid) processing protocol:

  1. microbiology: microscopic examination, standard cultivation test
  2. biochemistry: albumin, total protein
  3. Pathology: cytology
  4. PCR:

a. Multiplex PCR b. SARS-CoV-2 RNA load

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers dynamics in participants with superinfection in COVID-19 pneumonia
Time Frame: 28 days
To investigate the role of inflammatory markers (CRP, PCP, PSP, IL-6) as diagnostic tools for superinfection in COVID-19 pneumonia patients.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality from any cause
Time Frame: 28, 60, 90, 180, 360 days
To assess the association between hyperinflammatory phenotype and course of illness and mortality rates in COVID-19 pneumonia patients.
28, 60, 90, 180, 360 days

Collaborators and Investigators

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

Sponsor

Brno University Hospital

Collaborators

Masaryk University

Investigators

  • Principal Investigator: Jan Maláska, Brno University 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 (Actual)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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