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

NCT ID: NCT04199962

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-12

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sepsis Infection Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pneumonia without sepsis

adult patients with community acquired pneumonia change in SOFA score \<2 (other than respiratory component)

No interventions assigned to this group

pneumonia with sepsis

adult patients with community acquired pneumonia change in SOFA score greater or equal to 2 (other than respiratory component)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lowell Ling

Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Lowell Ling, FCICM

Role: CONTACT

+852 3505 1311

Gavin Joynt, FCICM

Role: CONTACT

+852 3505 1311

Facility Contacts

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Lowell Ling

Role: primary

3505 1311

Other Identifiers

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2019.372

Identifier Type: -

Identifier Source: org_study_id

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