Molecular Biomarkers for Sepsis

University Hospital, Basel, Switzerland3 enrolled

Overview

This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sepsis Severe Community-acquired Pneumonia (sCAP)Infection, Bacterial

Interventions

compare data patterns by data-driven algorithms to determine sepsis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admission to the ICU of one of the participating centers. * Cases: severe community acquired pneumonia with requirement for ICU admission. * Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever \>38°C, CRP \>100mg/L, no infection focus expected in ≥ 24h. * All required sample types can most likely be collected within the first 24h visits. * Expected ICU stay of more than 24h. Exclusion Criteria: * Admission to the hospital within the prior 14 days. * Patients with psychosis * Evidence of a hospital acquired pneumonia. * One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema. * Patients with an acute respiratory distress Syndrome (ARDS). * Patient which can be managed as outpatients and do not require an ICU. * Patient where a transmission to another institution is likely within the next 24h. * Documented rejection of the general consent or participation to research in general. * Patients with a palliative situation and a life expectancy due to other diseases (e.g. progressed cancer) less than 28 days.

Locations (15)

Clinical Bacteriology and Mycology, University Hospital Basel

Basel, Switzerland

Infectious Diseases and Hospital Epidemiology, University Hospital Basel

Basel, Switzerland

Intensive Care Unit; University Hospital Basel

Basel, Switzerland

Institute for Infectious Diseases, University of Bern

Bern, Switzerland

Infectious Diseases and Hospital Epidemiology, University Hospital Bern

Bern, Switzerland

Intensive Care Unit, University Hospital Bern

Bern, Switzerland

Clinical Bacteriology, University Hospital Geneva

Geneva, Switzerland

Infectious Diseases and Hospital Epidemiology, University Hospital Geneva

Geneva, Switzerland

Intensive Care Unit, University Hospital Geneva

Geneva, Switzerland

Clinical Microbiology, University Hospital Lausanne

Lausanne, Switzerland

...and 5 more locations

Outcomes

Primary Outcomes

Detection of sepsis

Sepsis detection based on new discovered digital biomarkers will be compared to classical sepsis-3 criteria (with an increase of the sequential organ failure assessment (SOFA) score of 2 or larger score points).

Time frame: within 7 days after study inclusion

Sepsis related mortality

Prediction of sepsis related mortality (with \>80% sensitivity and specificity at least 24h prior to event)

Time frame: within 7 days after study inclusion

Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)

Time to sepsis detection (minutes after ICU admission) based on machine learning

Time frame: within 7 days after study inclusion