SepsisNCT04199962
Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis
An observational study of Sepsis and Infection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Dec 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients admitted with community acquired pneumonia to a tertiary hospital in Hong Kong.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Lowell Ling, 3505 1311, lowell.ling@cuhk.edu.hk
Lowell Ling
About this study
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
This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.
Read the 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.
- Keywords
- sepsis, infection, pneumonia, organ dysfunction, critical illness
- Medical subject headings
- Sepsis, Infections, Pneumonia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
blood single cell transcriptome in infection and sepsis
comparison of single cell transcriptome between patients with uncomplicated pneumonia and pneumonia with sepsis
Measured: within 24 hours of hospital admission
Secondary outcomes (3)
blood single cell transcriptome as marker of organ dysfunction
association of single cell transcriptome with different types and severity of organ dysfunction
Measured: at time points 0, 24 and 72 hours
plasma DNA
comparison of plasma DNA with different types and severity of organ dysfunction
Measured: at time points 0, 24 and 72 hours
blood single cell transcriptome as predictor of clinical outcome
association of single cell transcriptome with mortality and morbidity outcomes
Measured: at time points 0, 24 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start12 Dec 2019
- Primary completion11 Nov 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lowell Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199962
- Sponsor's protocol ID
- 2019.372
- Status last verified
- Jan 2021
- First submitted
- 12 Dec 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04199962
- Acronym / sponsor ID
- 2019.372
- Keywords
- sepsis, infection, pneumonia, organ dysfunction, critical illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 11 Nov 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted with community acquired pneumonia to a tertiary hospital in Hong Kong.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
blood single cell transcriptome as marker of organ dysfunction
Time frame: at time points 0, 24 and 72 hours
plasma DNA
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lowell Ling, FCICM (+852 3505 1311, lowell.ling@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood single cell transcriptome in infection and sepsis (time frame: within 24 hours of hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.