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Trial History Detail on 2018-12-05

Form

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00623

2 Trial Registration Date

2018-09-05

i Registration Status

Prospective

3 Secondary IDs

Joint CUHK-NTEC Clinical Research Ethics Committee 2018.287

4 Source(s) of Funding

None

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lowell Ling

ii Address

4/F Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,
New Territories, Hong Kong

iii Phone

3505 2735

iv Email

lowell.ling@cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Lowell Ling

ii Address

4/F Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,
New Territories, Hong Kong

iii Phone

3505 2735

iv Email

lowell.ling@cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Genome wide expression in infection and sepsis: a pilot propsective cohort study

10 Public Title

Genome wide expression in infection and sepsis: a pilot propsective cohort study

i Public Title in Chinese 研究名稱

感染和膿毒症基因組廣泛表達：先導研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-07-21

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.287

14 Medical Condition Being Studied

sepsis

15 Intervention

i Types of intervention

Other

Please specify

This is not an intervention trial.

ii Description/ name of Intervention/article

This is not an intervention trial.

iii Dosage form of the intervention

This is not an intervention trial.

iv Dosage of the intervention

This is not an intervention trial.

v Duration of the intervention

This is not an intervention trial.

vi Frequency of the intervention

This is not an intervention trial.

16 Comparative Treatments

i Description/ name of comparative treatments

This is not an intervention trial.

ii Dosage form of the comparative treatments

This is not an intervention trial.

iii Dosage of the comparative treatments

This is not an intervention trial.

iv Duration of the comparative treatments

This is not an intervention trial.

v Frequency of the comparative treatments

This is not an intervention trial.

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

adult patients with susepcted communiy accquired pneumonia

ii Exclusion Criteria

immunosupression

current malignancy

chest symptoms not solely accounted by pneumonia (cardiac failure, non-cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome)

prisoner/cognitive impairment/age less than 18

hospitalization within 1 month

whole blood transfusion within 1 month

blood samples for gene expression could not be taken within 24 hours of admission

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

Feasibility of a genome wide expression study on patients with pneumonia with respect to recruitment, data collection and gene expression analysis

20 Anticipated trial start date

2018-10-01

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

feasibility of a genome wide expression study on patients with pneumonia

ii The metric or method of measurement used

recruitment rate, gene expression analysis

iii The timepoint(s) of primary interest

admission to hospital

24 Secondary Outcome

i The Name of the outcome

peripheral blood mononuclear cell genome wide expression differences uncomplicated pneumonia versus pneumonia with associated sepsis

ii The metric or method of measurement used

association of gene expression pattern and frequency of disease

iii The timepoint(s) of primary interest

admission to hospital

Secondary Outcome

i The Name of the outcome

peripheral blood mononuclear cell genome wide expression and association with organ dysfunction

ii The metric or method of measurement used

association of gene expression pattern and sequential organ failure assessment score

iii The timepoint(s) of primary interest

admission to hospital

Secondary Outcome

i The Name of the outcome

peripheral blood mononuclear cell genome wide expression and association with clnical outcomes

ii The metric or method of measurement used

association of gene expression pattern and clinical outcomes such as mortality, hospital length of stay

iii The timepoint(s) of primary interest

admission to hospital

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-12-06

27 Primary Registry and Trial Identifying Number

ChiCTR1800018535

28 Date of Registration in Primary Registry

2018-09-05

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