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A prospective study of Clostridium difficile infection and quality improvement initiative based on automatic CVR

Status Approved

First Submitted Date

2021/02/05
Registered Date

2021/02/16
Last Updated Date

2021/02/05

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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	KCT0005892
Unique Protocol ID	HC20OISI0075
Public/Brief Title	A prospective study of Clostridium difficile infection and quality improvement initiative based on automatic CVR
Scientific Title	A prospective study of Clostridium difficile infection and quality improvement initiative based on automatic CVR
Acronym
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	HC20OISI0075
Approval Date	2020-08-04
Institutional Review Board Name	Catholic Medical Center Bucheon St. Mary's Hospital Institutional Review Board
Institutional Review Board Address	327, Sosa-ro, Bucheon-si, Gyeonggi-do
Institutional Review Board Telephone	032-340-7540
Data Monitoring Committee	No

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	Tae-Geun Gweon
Title	Dr.
Telephone	+82-32-340-2228
Affiliation	The Catholic University of Korea, Bucheon St. Mary's Hospital
Address	Sosa-ro 327 Wonmi-Gu Bucheon-Si Kyungki-Do, 14647, Republic of Korea
Contact Person for Public Queries
Name	Tae-Geun Gweon
Title	Dr.
Telephone	+82-32-340-2228
Affiliation	The Catholic University of Korea, Bucheon St. Mary's Hospital
Address	Sosa-ro 327 Wonmi-Gu Bucheon-Si Kyungki-Do, 14647, Republic of Korea
Contact Person for Updating Information
Name	Tae-Geun Gweon
Title	Dr.
Telephone	+82-32-340-2228
Affiliation	The Catholic University of Korea, Bucheon St. Mary's Hospital
Address	Sosa-ro 327 Wonmi-Gu Bucheon-Si Kyungki-Do, 14647, Republic of Korea

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	Not yet recruiting
Date of First Enrollment	2021-03-01 Anticipated
Target Number of Participant	200
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Bucheon St. Mary's Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-03-01 ,

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	The Catholic University of Korea, Bucheon St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Bucheon St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	C. difficile infection (CDI) is a diarrheal disease, which is associated with gut dysbiosis. Most common cause of CDI is antibiotic treatment. Antibiotics are frequently used in various clinical setting. CDI patients are widely spread in various clinical department. CDI is diagnosed with stool study or endoscopy in combination with patient's symptom. Because the diagnosis of CDI is complex, its diagnosis is often delayed and improper treatment might be chosen. Infection and gastroenterology division are specialized for the treatment of CDI. To enhance quality of care, multidisciplinary approach and care is adopted for some diseases. To enhance quality of CDI care, our institute established CDI task force team consist gastroenterology, infection, and labaratory medicine. Critical value report system (CVR) is an automatic computer program which automatically report value of abnormal laboratory tests and vital signs which are critically related to safety of patients. When test for C.difficileI was positive, the results would be automatically reported to task force team using CVR program. The task force team can notice patients who were positive for C. difficile. The task force team evaluate the patient's clinical characteristics. The task force team prescribe additional tests and proper medication for CDI. The task force team can collect and control consecutive CDI patients. To date, prospective study for CDI has been rarely conducted in Korea. High quality data collection is essential for prospective study. The application of CVR program would improve patient's care and help conduct high quality prospective study including treatment efficacy and microbial characteristics.

Study Summary Information

Lay Summary

C. difficile infection (CDI) is a diarrheal disease, which is associated with gut dysbiosis. Most common cause of CDI is antibiotic treatment. Antibiotics are frequently used in various clinical setting. CDI patients are widely spread in various clinical department. CDI is diagnosed with stool study or endoscopy in combination with patient&#39;s symptom. Because the diagnosis of CDI is complex, its diagnosis is often delayed and improper treatment might be chosen.
Infection and gastroenterology division are specialized for the treatment of CDI. To enhance quality of care, multidisciplinary approach and care is adopted for some diseases.
To enhance quality of CDI care, our institute established CDI task force team consist gastroenterology, infection, and labaratory medicine.
Critical value report system (CVR) is an automatic computer program which automatically report value of abnormal laboratory tests and vital signs which are critically related to safety of patients. When test for C.difficileI was positive, the results would be automatically reported to task force team using CVR program.
The task force team can notice patients who were positive for C. difficile. The task force team evaluate the patient&#39;s clinical characteristics. The task force team prescribe additional tests and proper medication for CDI.
The task force team can collect and control consecutive CDI patients. To date, prospective study for CDI has been rarely conducted in Korea. High quality data collection is essential for prospective study. The application of CVR program would improve patient&#39;s care and help conduct high quality prospective study including treatment efficacy and microbial characteristics.

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	200
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Patients with of C. difficile infection
Cohort/ Group 1	Cohort/Group Description Consecutive patients whose stool test of C. difficile were positive
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients with C. difficile infection
Sampling Method	Among patients with diarrhea, positivity of stool test or presence of pseudomembranous colitis on endoscopy Stool test positivity - C. difficile PCR - C. difficile toxin - Toxigenic culture Pseudomembranous colitis
Condition(s)/Problem(s)	* (A00-B99)Certain infectious and parasitic diseases (B96.7)Clostridium perfringens [C. perfringens] as the cause of diseases classified to other chapters Clostridium difficile infection Clostridioides difficile infection
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description Stool test positivity - C. difficile PCR - C. difficile toxin - Toxigenic culture Pseudomembranous colitis
Exclusion Criteria	terminal cancer patients with life expectancy less than 1 month
Healthy Volunteers	No

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	Not applicable
Outcome	Time interval between diagnosis CDI and prescription of proper medication for CDI
Timepoint	7 days within diagnosis of CDI
Secondary Outcome(s) 1
Outcome	Rate of treatment success
Timepoint	14 days after treatment of CDI

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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