Molecular Biomarkers for Sepsis

Sepsis Clinical Trial

Official title:

Prospective Study to Discover New Biomarkers for Early Detection of Sepsis and Prediction of Sepsis-related Mortality in Patients With Severe Community Acquired Pneumonia (sCAP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04280354
• Other study ID #: 2020-00297;qu18Egli3
• Status: Terminated
• Start date: February 16, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• compare data patterns by data-driven algorithms to determine sepsis
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
• compare data patterns by data-driven algorithms to predict sepsis-related mortality
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality

Locations

Country	Name	City	State
Switzerland	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	Infectious Diseases and Hospital Epidemiology, University Hospital Bern	Bern
Switzerland	Institute for Infectious Diseases, University of Bern	Bern
Switzerland	Intensive Care Unit, University Hospital Bern	Bern
Switzerland	Clinical Bacteriology, University Hospital Geneva	Geneva
Switzerland	Intensive Care Unit, University Hospital Geneva	Geneva
Switzerland	Infectious Diseases and Hospital Epidemiology, University Hospital Geneva	Geneva,
Switzerland	Clinical Microbiology, University Hospital Lausanne	Lausanne
Switzerland	Infectious Diseases and Hospital Epidemiology , University Hospital Lausanne	Lausanne
Switzerland	Intensive Care Unit, University Hospital Lausanne	Lausanne
Switzerland	Infectious Diseases and Hospital Epidemiology, University Hospital Zurich	Zürich
Switzerland	Institute for Medical Microbiology, University Hospital Zurich	Zürich
Switzerland	Intensive Care Unit, University Hospital Zurich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich, Swiss Personalized Health Network (SPHN)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	within 7 days after study inclusion
Primary	Sepsis related mortality	Prediction of sepsis related mortality (with >80% sensitivity and specificity at least 24h prior to event)	within 7 days after study inclusion
Primary	Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)	Time to sepsis detection (minutes after ICU admission) based on machine learning	within 7 days after study inclusion