Clinical trial NCT04280354: Molecular Biomarkers for Sepsis
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sepsis
Severe Community-acquired Pneumonia (sCAP)
Infection, Bacterial
Keywords: Community-acquired Pneumonia
biomarker
clinical data warehouse (CDWH)
machine learning
data-driven algorithms
multi-dimensional modelling
sepsis-related mortality
Streptococcus pneumoniae
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Personalized Health Network (SPHN)
name: Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich
First posted: 2020-02-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients fulfilling the WHO-definition of a severe community acquired pneumonia (sCAP, cases) and patients with an inflammatory phenotype (controls) requiring intensive care medicine.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Detection of sepsis
timeFrame: within 7 days after study inclusion
measure: Sepsis related mortality
timeFrame: within 7 days after study inclusion
measure: Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)
timeFrame: within 7 days after study inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Bacteriology and Mycology, University Hospital Basel
city: Basel
country: Switzerland
facility: Infectious Diseases and Hospital Epidemiology, University Hospital Basel
city: Basel
country: Switzerland
facility: Intensive Care Unit; University Hospital Basel
city: Bern
country: Switzerland
facility: Institute for Infectious Diseases, University of Bern
city: Bern
country: Switzerland
facility: Infectious Diseases and Hospital Epidemiology, University Hospital Bern
city: Bern
country: Switzerland
facility: Intensive Care Unit, University Hospital Bern
city: Geneva,
country: Switzerland
facility: Infectious Diseases and Hospital Epidemiology, University Hospital Geneva
city: Geneva
country: Switzerland
facility: Clinical Bacteriology, University Hospital Geneva
city: Geneva
country: Switzerland
facility: Intensive Care Unit, University Hospital Geneva
city: Lausanne
country: Switzerland
facility: Clinical Microbiology, University Hospital Lausanne
city: Lausanne
country: Switzerland
facility: Infectious Diseases and Hospital Epidemiology , University Hospital Lausanne
city: Lausanne
country: Switzerland
facility: Intensive Care Unit, University Hospital Lausanne
city: Zürich
country: Switzerland
facility: Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
city: Zürich
country: Switzerland
facility: Institute for Medical Microbiology, University Hospital Zurich
city: Zürich
country: Switzerland
facility: Intensive Care Unit, University Hospital Zurich
Study officials:
affiliation: Clinical Microbiology, University Hospital Basel
name: Adrian Egli, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: