Molecular Biomarkers for Sepsis

University Hospital Basel

Status: Terminated

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

Treatments: Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality; Other: compare data patterns by data-driven algorithms to determine sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT04280354

2020-00297 qu18Egli3;

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 2 patient groups

patients with severe community acquired pneumonia (cases)

Description:

Cases: Patients with severe community acquired pneumonia with required ICU admission.

Treatment:

Other: compare data patterns by data-driven algorithms to determine sepsis

Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality

patients without pneumonia or sepsis (controls)

Description:

Controls: Clinical phenotype of inflammation not due to suspected sepsis; patients with fever \>38°C, C reactive Protein (CRP) \>100mg/L, no infection focus expected in ≥ 24h.

Treatment:

Other: compare data patterns by data-driven algorithms to determine sepsis

Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality