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

January 27, 2021 updated by: Lowell Ling, Chinese University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Lowell Ling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 24 hours of hospital admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at time points 0, 24 and 72 hours
plasma DNA
Time Frame: at time points 0, 24 and 72 hours
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
Time Frame: at time points 0, 24 and 72 hours
association of single cell transcriptome with mortality and morbidity outcomes
at time points 0, 24 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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