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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04867161

Acronym

SUPER-HI

Enrollment

300

Registered

2021-04-30

Start date

2020-12-21

Completion date

2022-12-31

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia, Superinfection Lung

Keywords

COVID-19, superinfection, inflammatory markers

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.

Interventions

DIAGNOSTIC_TESTInflammatory 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

none \-

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Mortality from any cause	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.

Countries

Czechia

Contacts

Primary ContactJan Maláska

jan.malaska@gmail.com+420532232009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026