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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Sepsis; Infection

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Lowell Ling, FCICM; Phone Number: +852 3505 1311; Email: lowell.ling@cuhk.edu.hk
• Study Contact Backup: Name: Gavin Joynt, FCICM; Phone Number: +852 3505 1311; Email: gavinmjoynt@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Lowell Ling; Phone Number: 3505 1311; Email: lowell.ling@cuhk.edu.hk
    • Principal Investigator: Lowell Ling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted with community acquired pneumonia to a tertiary hospital in Hong Kong.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
pneumonia without sepsis; adult patients with community acquired pneumonia change in SOFA score <2 (other than respiratory component)
pneumonia with sepsis; adult patients with community acquired pneumonia change in SOFA score greater or equal to 2 (other than respiratory component)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Anticipated): November 11, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: infection; pneumonia; sepsis; organ dysfunction; critical illness
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Infections; Pneumonia
• Other Study ID Numbers: 2019.372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No