Status Approved
First Submitted Date
2021/03/12
Registered Date
2021/03/16
Last Updated Date
2024/01/23
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006008 |
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Unique Protocol ID | XC20MNDI0157 |
Public/Brief Title | Optimized antibiotic treatment in Korean patients with Clostroides difficile infection |
Scientific Title | Comparative study for optimized antibiotic treatment in Korean patients with Clostroides difficile infection |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | XC20MNDI0157K |
Approval Date | 2021-02-18 |
Institutional Review Board Name | Catholic medical center Institutional Review Board (IRB) |
Institutional Review Board Address | 222, Banpo-daero, Seocho-gu, Seoul |
Institutional Review Board Telephone | 02-2258-8203 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Young-Seok Cho |
Title | prof |
Telephone | +82-2-1588-1511 |
Affiliation | The Catholic University of Korea, Seoul St. Mary's Hospital |
Address | 222 BANPO-DAERO, SEOCHO-GU, SEOU |
Contact Person for Public Queries | |
Name | Young-Seok Cho |
Title | prof |
Telephone | +82-2-1588-1511 |
Affiliation | The Catholic University of Korea, Seoul St. Mary's Hospital |
Address | 222 BANPO-DAERO, SEOCHO-GU, SEOU |
Contact Person for Updating Information | |
Name | Koeun Choi |
Title | Clinical Research Coordinator |
Telephone | +82-2-2258-2083 |
Affiliation | The Catholic University of Korea, Seoul St. Mary's Hospital |
Address | 222 BANPO-DAERO, SEOCHO-GU, SEOU |
4. Status
Study Site | Multi-center Number of center : 9 | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-06-16 Actual | |
Target Number of Participant | 438 | |
Primary Completion Date | 2024-12-31 , Anticipated | |
Study Completion Date | 2024-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | The Catholic University of Korea, Seoul St. Mary's Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-06-16 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | The Catholic University of Korea, Bucheon St. Mary's Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-07-09 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | The Catholic University of Korea, St. Vincent's Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-12-23 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | Keimyung University Dongsan Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-10-26 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | The Catholic University of Korea, Daejeon St. Mary's Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-11-10 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-11-25 , | |
Recruitment Status by Participating Study Site 7 | ||
Name of Study | Yeongnam University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-02-19 , | |
Recruitment Status by Participating Study Site 8 | ||
Name of Study | Chung-Ang Univerisity Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-08-28 , | |
Recruitment Status by Participating Study Site 9 | ||
Name of Study | Hallym University Medical Center-Kangnam | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-06-30 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea Health Industry Development Institute |
Organization Type | Government |
Project ID | HC20C0099 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea, Seoul St. Mary's Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Study purpose primary purpose We develop treatment guidelines suitable for domestic diseases by comparing and evaluating antibiotic treatment for korean CDI patients. secondary purpose We examine fecal samples in order to establish the basis for korean CDI ribotyping data and analysis of antibiotic resistance. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Investigator |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | We compare metronidazole and vancomycin use groups in mild and moderate C. difficile infections and metronidazole and vancomycin use groups in severe Clostroides difficile infections. For metronidazole tablets, 500 mg is taken orally 3 times a day. It is usually treated for 10 days. For metronidazole injections, 500 mg (100 mL) is administered intravenously at a rate of 25 mg (5 mL) per minute every 8 hours. In the case of vancomycin capsules, 125 mg is taken orally 4 times a day and administered orally for 10 days. If oral administration is not possible, it is given intrarectally. |
Number of Arms | 4 |
Arm 1 |
Arm Label Use of metronidazole in mild to modrate clostridium infection |
Target Number of Participant 108 |
|
Arm Type Experimental |
|
Arm Description For metronidazole tablets, 500 mg is taken orally 3 times a day. It is usually treated for 10 days. For metronidazole injections, 500 mg (100 mL) is administered intravenously at a rate of 25 mg (5 mL) per minute every 8 hours. |
|
Arm 2 |
Arm Label Use of metronidazole in severe clostridium infection |
Target Number of Participant 111 |
|
Arm Type Experimental |
|
Arm Description For metronidazole tablets, 500 mg is taken orally 3 times a day. It is usually treated for 10 days. For metronidazole injections, 500 mg (100 mL) is administered intravenously at a rate of 25 mg (5 mL) per minute every 8 hours. |
|
Arm 3 |
Arm Label Use of vancomycin in mild to modrate clostridium infection |
Target Number of Participant 108 |
|
Arm Type Active comparator |
|
Arm Description In the case of vancomycin capsules, 125 mg is taken orally 4 times a day and administered orally for 10 days. If oral administration is not possible, it is given intrarectally. |
|
Arm 4 |
Arm Label Use of vancomycin in severe clostridium infection |
Target Number of Participant 111 |
|
Arm Type Active comparator |
|
Arm Description In the case of vancomycin capsules, 125 mg is taken orally 4 times a day and administered orally for 10 days. If oral administration is not possible, it is given intrarectally. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (A00-B99)Certain infectious and parasitic diseases (A04.7)Enterocolitis due to Clostridium difficile Clostridioides difficile infection |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~85Year |
|
Description Inclusion criteria Adults aged 19 to 85, patients with clinical symptoms, laboratory tests confirmed CDI. Patients not receiving CDI treatment in the past 10 days Patients of childbearing potential who are not pregnant prior to participation in the clinical trial |
|
Exclusion Criteria |
Exclusion criteria Patients who have experienced at least one CDI within 3 months prior to participation in the clinical trial Patients taking to be treated with prohibited medications Pregnant or lactating women Patients with ulcerative colitis or Crohn's disease Patients undergone colon resection Patients has a current diagnosis of toxic megacolon Patient has hypersensitivity to metronidazole Patients has hypersensitivity to vancomycin |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Cure Rate at End of Therapy |
|
Timepoint | Study day 10 (+/-2 days) |
|
Secondary Outcome(s) 1 | ||
Outcome | Recurrence |
|
Timepoint | Study days 11-40 |
|
Secondary Outcome(s) 2 | ||
Outcome | Global Cure |
|
Timepoint | End of Study (Day 40) |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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