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Development of imaging-based identification of pathogenic bacteria and antibiotic susceptibility in patients with bacteremia

Status Approved

First Submitted Date

2021/02/19
Registered Date

2021/03/04
Last Updated Date

2021/02/23

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005947
Unique Protocol ID	B-1812-511-304
Public/Brief Title	Development of identification of pathogenic bacteria and antibiotic susceptibility in patients with bacteremia
Scientific Title	Development of imaging-based identification of pathogenic bacteria and antibiotic susceptibility in patients with bacteremia
Acronym	옵소닌
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-1812-511-304
Approval Date	2018-12-13
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	Yes Research Committee, Dept. of Emergency Medicine, Seoul National University Bundang Hospital

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jae Hyuk Lee
Title	Dr.
Telephone	+82-31-787-7579
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Contact Person for Public Queries
Name	Inwon Park
Title	Dr.
Telephone	+82-31-787-7579
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Contact Person for Updating Information
Name	Inwon Park
Title	Dr.
Telephone	+82-31-787-7579
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-01-06 Actual
Target Number of Participant	125
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-01-06 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Government
Project ID	NRF-2017M3A9E2062210

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study was aimed to develop multiplexed FISH in a microfluidic device that facilitates the diagnosis of bacteremia.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	125
Cohort/Group Number	3
Cohort/ Group 1	Cohort/Group Label Patients with suspected bacteremia
Cohort/ Group 1	Cohort/Group Description Patients with suspected bacteremia
Cohort/ Group 2	Cohort/Group Label Patients with systemic inflammatory response, but no bacteremia
Cohort/ Group 2	Cohort/Group Description Patients who visited the hospital due to cardiac arrest, with no suspected infection and bacteremia
Cohort/ Group 3	Cohort/Group Label Healthy Controls
Cohort/ Group 3	Cohort/Group Description Healthy controls without signs of infection
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample with DNA
Biospecimen Description	Whole blood

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	- Patients with bacteremia: patients who visit the emergency department - Patients with systemic inflammation, but not bacteremia: patients who visit the emergency department - Healthy controls: recruited from the advertisement
Sampling Method	- Patients with bacteremia: simple random sampling from patients who visit the emergency department with fever (BT > 37.8) and Signs of infection - Patients with systemic inflammation, but not bacteremia: simple random sampling from patients who visit the emergency department due to cardiac arrest, but no signs of infection - Healthy controls: simple random sampling recruited from the advertisement that has no signs of infection
Condition(s)/Problem(s)	* (A00-B99)Certain infectious and parasitic diseases (A41.9)Sepsis, unspecified Bacteremia Sepsis
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description - Patients with suspected bacteremia: Among adult patients over 19 years of age who visited the emergency room of Seoul National University Bundang Hospital, a subject with a possibility of bacteremia is defined as follows: A fever of 37.8'C or higher was confirmed at the time of admission to the emergency room or while hospitalized in the emergency room, and blood culture was performed to confirm bacteremia. - Patients with systemic inflammation, but not bacteremia: Among adult patients over 19 years of age who visited the emergency room of Seoul National University Bundang Hospital for cardiac arrest, no infection was suspected, and patients who would use hypothermic treatment and prophylactic antibiotics. - Healthy controls: Those who were recruited through the recruitment announcement among adults over 19 years of age and who did not have any symptoms of infection.
Exclusion Criteria	1. Patients under age 19 2. Patients who refuse to enroll in the study
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Rapid identification of bacteremia
Timepoint	5 days after blood culture
Secondary Outcome(s) 1
Outcome	Time to positivity of bacteria identification
Timepoint	Before 5 days after blood culture

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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