Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis

Study Overview
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Brief Summary
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This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

Detailed Description
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This is a prospective cohort study using single cell transcriptomic profiling and plasma DNA tissue mapping on patients with pneumonia with or without sepsis. The major application of the investigator's study would be the discovery of gene expressions in different leucocytes and plasma DNA associated with each type of organ dysfunction in sepsis. These include cardiovascular, respiratory, hepatic, renal, neurological and haematological dysfunction. This would help prediction, diagnosis and development of therapies to treat sepsis. Leucocyte single cell transcriptome and plasma DNA tissue mapping may addresses the limitations of current evidence in 3 ways: (1) differentiate patients with uncomplicated pneumonia versus pneumonia with associated sepsis, (2) correlation with types and severity of organ dysfunction and (3) identifying molecular phenotypes of sepsis.

Official Title
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Genomic Approaches for Predicting Severity of Organ Dysfunction and Outcomes in Sepsis: a Prospective Cohort Study in Adult Critically Ill Patients With Sepsis

Conditions
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Sepsis, Infection, Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of the following: newly admitted adult patients (≥ 18 years old) suspected community acquired pneumonia (CAP) compatible history of either sputum or cough or fever or rigors within 1 week chest X-ray infiltrates Exclusion Criteria: Any of the following: chest symptoms not solely accounted by pneumonia (cardiac failure, non cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome) immunosuppression current malignancy blood samples for gene expression could not be taken within 24 hours of admission prisoner/cogni tive impairment blood transfusion within 1 month hospitalization within 1 month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pneumonia without sepsis<br>adult patients with community acquired pneumonia change in SOFA score <2 (other than respiratory component) | |
| pneumonia with sepsis<br>adult patients with community acquired pneumonia change in SOFA score greater or equal to 2 (other than respiratory component) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood single cell transcriptome in infection and sepsis | comparison of single cell transcriptome between patients with uncomplicated pneumonia and pneumonia with sepsis | within 24 hours of hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood single cell transcriptome as marker of organ dysfunction | association of single cell transcriptome with different types and severity of organ dysfunction | at time points 0, 24 and 72 hours | 
| plasma DNA | comparison of plasma DNA with different types and severity of organ dysfunction | at time points 0, 24 and 72 hours | 
| blood single cell transcriptome as predictor of clinical outcome | association of single cell transcriptome with mortality and morbidity outcomes | at time points 0, 24 and 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, infection, pneumonia, organ dysfunction, critical illness