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

NCT04867161 | Unknown

• 1 other identifier: 146/20
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia; Superinfection Lung

Keywords

COVID-19; superinfection; inflammatory markers

Outcome Measures

Primary Outcomes (1)

• Inflammatory markers dynamics in participants with superinfection in COVID-19 pneumonia

  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 Outcomes (1)

• Mortality from any cause

  28, 60, 90, 180, 360 days

Study Arms (2)

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

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

Interventions

Inflammatory markers sampling 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 COVID-19 pneumonia without superinfection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• admission on ICU
• age more than 18 years
• COVID-19 pneumonia criteria fulfilled

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk University: collaborator

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

RECRUITING

Related Publications (5)

• 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.

  PMID: 32358954 BACKGROUND

• 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.

  PMID: 32473235 BACKGROUND

• Keddie S, Ziff O, Chou MKL, Taylor RL, Heslegrave A, Garr E, Lakdawala N, Church A, Ludwig D, Manson J, Scully M, Nastouli E, Chapman MD, Hart M, Lunn MP. Laboratory biomarkers associated with COVID-19 severity and management. Clin Immunol. 2020 Dec;221:108614. doi: 10.1016/j.clim.2020.108614. Epub 2020 Oct 22.

  PMID: 33153974 BACKGROUND

• 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.

  PMID: 32864628 BACKGROUND

• 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.

  PMID: 32539990 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum samples and bronchoalveolar fluid samples are stored in aliquots

MeSH Terms

Conditions

COVID-19; Superinfection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Opportunistic Infections

Study Officials

• Jan Maláska

  Brno University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Maláska

CONTACT

+420532232009; jan.malaska@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: December 21, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

CZ (1)