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

Brno University Hospital

Status: Enrolling

Conditions: COVID-19 Pneumonia; Superinfection Lung

Treatments: Diagnostic Test: Inflammatory markers sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04867161

146/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria: none

Trial design

300 participants in 2 patient groups

Patients with COVID-19 pneumonia without superinfection

Description:

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 )

Treatment:

Diagnostic Test: Inflammatory markers sampling

Patients with COVID-19 pneumonia with superinfection

Description:

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 )

Treatment:

Diagnostic Test: Inflammatory markers sampling