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

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

Study Description
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Brief Summary:
This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

Condition or disease
Sepsis Infection 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 Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Sepsis

Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. plasma DNA [ Time Frame: at time points 0, 24 and 72 hours ]
    comparison of plasma DNA with different types and severity of organ dysfunction

  3. 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


Biospecimen Retention:   Samples With DNA
single-cell suspension and plasma DNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199962


Contacts
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Contact: Lowell Ling, FCICM +852 3505 1311 lowell.ling@cuhk.edu.hk
Contact: Gavin Joynt, FCICM +852 3505 1311 gavinmjoynt@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Lowell Ling    3505 1311    lowell.ling@cuhk.edu.hk   
Principal Investigator: Lowell Ling         
Sponsors and Collaborators
Chinese University of Hong Kong
More Information
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Responsible Party: Lowell Ling, Clinical Lecturer, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04199962    
Other Study ID Numbers: 2019.372
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lowell Ling, Chinese University of Hong Kong:
sepsis
infection
pneumonia
organ dysfunction
critical illness
Additional relevant MeSH terms:
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Infections
Pneumonia
Sepsis
Toxemia
Pathologic Processes
 Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation