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Comparative study for optimized antibiotic treatment in Korean patients with Clostroides difficile infection

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

    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
    KCT0006008
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 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 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

    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
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Health Industry Development Institute
    Organization Type Government
    Project ID HC20C0099
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    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

    Subject Eligibility Information
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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

    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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