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

NCT ID: NCT04867161

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2022-12-31

Brief Summary

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.

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.

Conditions

COVID-19 Pneumonia; Superinfection Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 )

Inflammatory markers sampling

Intervention Type: DIAGNOSTIC_TEST

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 )

Inflammatory markers sampling

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. admission on ICU

2. age more than 18 years

3. COVID-19 pneumonia criteria fulfilled

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk University

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jan Malaska

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Maláska

Role: PRINCIPAL_INVESTIGATOR

Brno University Hospital

Locations

University Hospital Brno

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jan Maláska

Role: CONTACT

jan.malaska@gmail.com

+420532232009

Facility Contacts

Jan Maláska

Role: primary

jan.malaska@gmail.com

+420723784101

Jan Stašek

Role: backup

janstasek@centrum.cz

+420532232009

References

Rawson TM, Moore LSP, Zhu N, Ranganathan N, Skolimowska K, Gilchrist M, Satta G, Cooke G, Holmes A. Bacterial and Fungal Coinfection in Individuals With Coronavirus: A Rapid Review To Support COVID-19 Antimicrobial Prescribing. Clin Infect Dis. 2020 Dec 3;71(9):2459-2468. doi: 10.1093/cid/ciaa530.

Reference Type: BACKGROUND

PMID: 32358954 (View on PubMed)

Lansbury L, Lim B, Baskaran V, Lim WS. Co-infections in people with COVID-19: a systematic review and meta-analysis. J Infect. 2020 Aug;81(2):266-275. doi: 10.1016/j.jinf.2020.05.046. Epub 2020 May 27.

Reference Type: BACKGROUND

PMID: 32473235 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33153974 (View on PubMed)

Manson JJ, Crooks C, Naja M, Ledlie A, Goulden B, Liddle T, Khan E, Mehta P, Martin-Gutierrez L, Waddington KE, Robinson GA, Ribeiro Santos L, McLoughlin E, Snell A, Adeney C, Schim van der Loeff I, Baker KF, Duncan CJA, Hanrath AT, Lendrem BC, De Soyza A, Peng J, J'Bari H, Greenwood M, Hawkins E, Peckham H, Marks M, Rampling T, Luintel A, Williams B, Brown M, Singer M, West J, Jury EC, Collin M, Tattersall RS. COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study. Lancet Rheumatol. 2020 Oct;2(10):e594-e602. doi: 10.1016/S2665-9913(20)30275-7. Epub 2020 Aug 21.

Reference Type: BACKGROUND

PMID: 32864628 (View on PubMed)

WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12.

Reference Type: BACKGROUND

PMID: 32539990 (View on PubMed)

Other Identifiers

146/20

Identifier Type: -

Identifier Source: org_study_id