Clinical trial NCT04867161: Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients
Official title: Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients (SUPER-HI) - Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Superinfection Lung
Keywords: COVID-19
superinfection
inflammatory markers
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2021-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria: none

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Primary outcomes:
measure: Inflammatory markers dynamics in participants with superinfection in COVID-19 pneumonia
timeFrame: 28 days
Secondary outcomes:
measure: Mortality from any cause
timeFrame: 28, 60, 90, 180, 360 days
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: Brno University Hospital
name: Jan Maláska
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.