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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199962
• Other study ID #: 2019.372
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Chinese University of Hong Kong
• Contact: Lowell Ling, FCICM
• Phone: +852 3505 1311
• Email: lowell.ling[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: November 11, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Pneumonia
• Sepsis
• Toxemia

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	plasma DNA	comparison of plasma DNA with different types and severity of organ dysfunction	at time points 0, 24 and 72 hours
Secondary	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