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

• Conditions: Infection; Sepsis; Pneumonia

• Registration Number: NCT04199962
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-12-12
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29
• Primary Completion: 2022-11-11
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood single cell transcriptome in infection and sepsis	within 24 hours of hospital admission	comparison of single cell transcriptome between patients with uncomplicated pneumonia and pneumonia with sepsis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong