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An exploratory clinical trial to evaluate the clinical benefit of AUC-based vancomycin TDM in Korean patients with MRSA infection

Status Approved

  • First Submitted Date

    2021/03/13

  • Registered Date

    2021/03/24

  • Last Updated Date

    2021/03/16

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
    KCT0006018
    Unique Protocol ID KNUH-2021-02-003-001
    Public/Brief Title An exploratory clinical trial for optimizing vancomycin therapy in Korean patients with MRSA infection
    Scientific Title An exploratory clinical trial to evaluate the clinical benefit of AUC-based vancomycin TDM in Korean patients with MRSA infection
    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 KNUH-2021-02-003-001
    Approval Date 2021-03-05
    Institutional Review Board Name Kangwon National University Hospital Institutional Review Board
    Institutional Review Board Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do
    Institutional Review Board Telephone 033-258-9199
    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 Ji In Park
    Title Assistant professor
    Telephone +82-33-258-9204
    Affiliation Kangwon National University Hospital
    Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
    Contact Person for Public Queries
    Name Sang-In Park
    Title Assistant professor
    Telephone +82-33-250-8851
    Affiliation Kangwon National University
    Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
    Contact Person for Updating Information
    Name Ji In Park
    Title Assistant professor
    Telephone +82-33-258-9204
    Affiliation Kangwon National University Hospital
    Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do, 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
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-03-22 Anticipated
    Target Number of Participant 80
    Primary Completion Date 2023-02-28 , Anticipated
    Study Completion Date 2023-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Kangwon National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-03-22 ,
  • 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 Kangwon National University Hospital
    Organization Type Medical Institute
    Project ID KNUH-2021-02-003-001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kangwon National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The aim of this study is to evaluate the relationship between the pharmacokinetic (PK) endpoints (i.e., AUC) and clinical effects or the occurrence of nephrotoxicity by performing therapeutic drug monitoring (TDM) in Korean patients with MRSA infection.
    -Subjects registered before the initiation of vancomycin administration should perform baseline examinations within 2 weeks prior to vancomycin administration. In the case of subjects registered after the initiation of dosing, baseline information can be collected retrospectively, or baseline tests can be conducted within 3 days after the initiation of dosing.
    -On day 1(before vancomycin administration) and days 2-7 after the initiation of vancomycin administration, urine collection will be performed for biomarker exploration.
    -On days 3, 7, and 10, blood samples will be collected For PK evaluation at 1.5 h (between 1-2 h) after the end of intravenous administration and 30 minutes before the next dose (trough level) with clinical laboratory tests (creatinine, cystatin C). Blood collection for TDM will be performed approximately twice per patient and may vary depending on the dosing schedule and renal function. 
    -In this study, blood samples collected in the Biobank of Kangwon National University Hospital will be used for genotype analysis.
  • 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 80
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Korean patients who are expected to receive vancomycin for 7 days or more for the treatment of MRSA infection, or within 3 days after initiation of vancomycin administration

    Cohort/Group Description

    These study procedures will be conducted in Korean patients who are expected to receive vancomycin for 7 days or more for the treatment of MRSA infection, or within 3 days after initiation of vancomycin administration.
    1. The baseline tests (demographic information collection, clinical laboratory tests, exploratory biomarker tests, etc.) are conducted to the enrolled patients within 2 weeks before initiation of the vancomycin dosing. 
    2. On day 1(before vancomycin administration) and days 2-7 after the initiation of vancomycin administration, urine collection will be performed for biomarker exploration. 
    3. On days 3, 7, and 10, blood samples will be collected for PK evaluation at 1.5 h (between 1-2 h) after the end of intravenous administration and 30 minutes before the next dose (trough level) with clinical laboratory tests (creatinine, cystatin C). Blood collection for TDM will be performed approximately twice per patient and may vary depending on the dosing schedule and renal function. 
    4. In this study, blood samples collected in the Biobank of Kangwon National University Hospital will be used for genotype analysis.
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description
    Urine
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Men and women over 19 years of age who were decided to administer vancomycin due to MRSA infection at Kangwon National University Hospital
    Sampling Method
    Non-probablity sampling: All men and women over 19 years of age who were decided to administer vancomycin due to MRSA infection at Kangwon National University Hospital and selected for this study will be enrolled.
    Condition(s)/Problem(s) * (A00-B99)Certain infectious and parasitic diseases 
       (A49.0)Staphylococcal infection, unspecified site 

    Methicillin-Resistant Staphylococcus aureus
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    ① Patients who have the ability to sign the consent form in accordance with GCP and corresponding laws
    ② Patients who are 19 years or older
    ③ Patients who were decided to administer vancomycin for 7 days or more due to MRSA infection or within 3 days after initiation of vancomycin dosing
    ④ Patient who understands the contents of the clinical research and provide their written informed consent forms
    Exclusion Criteria
    ① Patients who co-administered vancomycin, except for the intravenous route. (e.g., per oral)
    ② Patients with contraindications for vancomycin (e.g., Anaphylaxis due to vancomycin) 
    ③ Patients in pregnancy or lactation 
    ④ Patients whom the researcher deemed inappropriate for clinical research participation
    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 Pharmacokinetics
    Primary Outcome(s) 1
    Outcome
    Pharmacokinetic parameters (AUC, Ctrough)
    Timepoint
    Day 3, Day 7, and Day 10 after initiation of vancomycin dosing
    Secondary Outcome(s) 1
    Outcome
    Occurrence of nephrotoxicity
    Timepoint
    Prior to vancomycin dosing(Day 1) and Days 2-7 after initiation of vancomycin dosing
  • 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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