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

• ClinicalTrials.gov Identifier: NCT04199962
• Recruitment Status: Unknown
• First Posted: December 16, 2019
• Last Update Posted: January 29, 2021
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Lowell Ling, Chinese University of Hong Kong

Tracking Information

• First Submitted Date: December 12, 2019
• First Posted Date: December 16, 2019
• Last Update Posted Date: January 29, 2021
• Actual Study Start Date: December 12, 2019
• Estimated Primary Completion Date: November 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2019)

blood single cell transcriptome in infection and sepsis [ Time Frame: within 24 hours of hospital admission ]

comparison of single cell transcriptome between patients with uncomplicated pneumonia and pneumonia with sepsis

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 13, 2019)

• blood single cell transcriptome as marker of organ dysfunction [ Time Frame: at time points 0, 24 and 72 hours ]
  association of single cell transcriptome with different types and severity of organ dysfunction
• plasma DNA [ Time Frame: 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 [ Time Frame: at time points 0, 24 and 72 hours ]
  association of single cell transcriptome with mortality and morbidity outcomes

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis
• 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
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

single-cell suspension and plasma DNA

• Sampling Method: Non-Probability Sample
• Study Population: All adult patients admitted with community acquired pneumonia to a tertiary hospital in Hong Kong.

Condition

• Sepsis
• Infection
• Pneumonia

• Intervention: Not Provided

Study Groups/Cohorts

• 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)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 13, 2019): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: November 11, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT04199962
• Other Study ID Numbers: 2019.372
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Lowell Ling, Chinese University of Hong Kong
• Original Responsible Party: Same as current
• Current Study Sponsor: Chinese University of Hong Kong
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chinese University of Hong Kong
• Verification Date: January 2021