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

NCT04199962 | Unknown

• 1 other identifier: 2019.372
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis; Infection; Pneumonia

Keywords

sepsis; infection; pneumonia; organ dysfunction; critical illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• blood single cell transcriptome as marker of organ dysfunction

  at time points 0, 24 and 72 hours

• plasma DNA

  at time points 0, 24 and 72 hours

• blood single cell transcriptome as predictor of clinical outcome

  at time points 0, 24 and 72 hours

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

single-cell suspension and plasma DNA

MeSH Terms

Conditions

Sepsis; Infections; Pneumonia; Critical Illness

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes

Central Study Contacts

Lowell Ling, FCICM

CONTACT

+852 3505 1311; lowell.ling@cuhk.edu.hk

Gavin Joynt, FCICM

CONTACT

+852 3505 1311; gavinmjoynt@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: December 12, 2019
• Primary Completion: November 11, 2022
• Study Completion: December 31, 2023
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

HK (1)