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A clinical study to evaluate the intrapulmonary pharmacokinetics of vancomycin and to explore biomarkers for nephrotoxicity in critically ill patients with pneumonia

Status Approved

  • First Submitted Date

    2020/12/15

  • Registered Date

    2020/12/31

  • Last Updated Date

    2021/12/02

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
    KCT0005729
    Unique Protocol ID KH-VANC-03
    Public/Brief Title A clinical study to evaluate the intrapulmonary pharmacokinetics of vancomycin and to explore biomarkers for nephrotoxicity in critically ill patients with pneumonia
    Scientific Title A clinical study to evaluate the intrapulmonary pharmacokinetics of vancomycin and to explore biomarkers for nephrotoxicity in critically ill patients with pneumonia
    Acronym KH-VANC-03
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KHUH 2020-11-006-003
    Approval Date 2020-12-15
    Institutional Review Board Name Kyung Hee University Hospital Institutional Review Board Membership
    Institutional Review Board Address 23, Kyungheedae-ro, Dongdaemun-gu, Seoul
    Institutional Review Board Telephone 02-958-9579
    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 Bo-Hyung Kim
    Title professor
    Telephone +82-2-958-2913
    Affiliation Kyung Hee University Hospital
    Address 23, Kyungheedae-ro, Dongdaemun-gu, Seoul
    Contact Person for Public Queries
    Name Sooyoung Lee
    Title Researcher
    Telephone +82-2-961-2269
    Affiliation Kyung Hee University Hospital
    Address 23, Kyungheedae-ro, Dongdaemun-gu, Seoul
    Contact Person for Updating Information
    Name Sooyoung Lee
    Title Researcher
    Telephone +82-2-961-2269
    Affiliation Kyung Hee University Hospital
    Address 23, Kyungheedae-ro, Dongdaemun-gu, Seoul
  • 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 2021-04-01 Actual
    Target Number of Participant 24
    Primary Completion Date 2022-09-01 , Anticipated
    Study Completion Date 2022-11-11 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Kyung Hee University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-04-01 ,
  • 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 National Research Foundation
    Organization Type Government
    Project ID 2019R1C1C1011218
  • 6. Sponsor Organization

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

    Study Summary Information
    Lay Summary
    It is necessary to study producing pharmacokinetic parameters for appropriately therapeutic drug monitoring. Successful treatment of infectious disease needs to understand the delivery of antibiotics to the area of infection. However, there are very few studies of vancomycin intrapulmonary pharmacokinetic study of pneumonia patients with the pulmonary area of infection. So, we will investigate the intrapulmonary pharmacokinetic study in Korean patients. And, we will also investigate the suitable biomarkers to predict the nephrotoxicity with vancomycin administration. When the vancomycin is used on seriously infectious patients who cannot use other antibiotics because of resistances or adverse events, nephrotoxicity can be a serious problem that drug discontinuation should be taken into consideration. Therefore, We will investigate the nephrotoxicity with novel nephrotoxicity biomarkers. By investigating like this pharmacokinetic and biomarkers exploring, if the suitable pharmacokinetic parameters and biomarkers for vancomycin in Korean patients will be produced, it is expected to improve the successful treatment of patients.
  • 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 Phase1
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Drug  
    Intervention Description
    Only patients who be provided written informed consent by their own self or patient's legally authorized representative undergo screening assessment prior to the first PK sampling day to determine their eligibility for enrollment into the study. Subjects who enrolled will be conducted first PK sampling within 7 days from informed consent, that day names day 1, and that day administration names PK administration. The vancomycin will be administered by intravenous infusion. But, The infusion time is 1 hour. The dosage will be determined by TDM or clinician's opinion based on 'The Sanford guide to antimicrobial therapy(熱病)'. By planned study schedules, Blood sampling is conducted for pharmacokinetic assessments, BAL is conducted for BALF collection at only 1 point by each subject. From day 2, PK blood sampling is conducted only when TDM is conducted, and BALF is collected only when BAL is conducted. For the evaluation of nephrotoxicity biomarkers, blood sampling is conducted at 1~7 days and urine sampling is conducted at 1, 4 days. On the 7th day from the first PK sampling, the study is complete.
    Number of Arms 1
    Arm 1

    Arm Label

    Experimental arm

    Target Number of Participant

    24

    Arm Type

    Experimental

    Arm Description

    Subjects will be conducted first PK sampling within 7 days from informed consent, that day names day 1, and that day administration names PK administration. The vancomycin will be administered by intravenous infusion. But, The infusion time is 1 hour. The dosage will be determined by TDM or clinician's opinion based on 'The Sanford guide to antimicrobial therapy(熱病)'. By planned study schedules, Blood sampling is conducted for pharmacokinetic assessments, BAL is conducted for BALF collection at only 1 point by each subject. From day 2, PK blood sampling is conducted only when TDM is conducted, and BALF is collected only when BAL is conducted. For the evaluation of nephrotoxicity biomarkers, blood sampling is conducted at 1~7 days and urine sampling is conducted at 1, 4 days. On the 7th day from the first PK sampling, the study is complete.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (J00-J99)Diseases of the respiratory system 
       (J18.9)Pneumonia, unspecified 

    suspicion or diagnosis of pneumonia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1) 19 years of age or older
    2) Patient has provided written informed consent or informed consent has been provided by the patient's legally authorized representative
    3) Patient has a suitability for the administration of vancomycin as a clinical manifestation
    4) Patient has suspicion or diagnosis of bacterial pneumonia
    5) Patient has a requirement for the collection of BALF for diagnosis/treatment
    Exclusion Criteria
    1) Patient has a history of any shock or hypersensitivity against the investigational product or aminoglycoside antibiotics
    2) Patient has contraindications and/or precautions to investigational product (who have an underlying hearing loss, who are receiving concomitant therapy with another ototoxic agent, such as aminoglycosides or peptide antibiotics, who have vestibular and/or cochlear injury)
    3) Imminent death within 48 hours
    4) Pregnant or breastfeeding women
    5) Patients has contraindications to bronchoalveolar lavage
    6) Patients has hypersensitivity to medications associated with the bronchoalveolar lavage procedures, such as local anesthetics, sedatives, pain control medications
    7) Patient has a requirement for extracorporeal membrane oxygenation(ECMO) therapy
    8) Patient has a requirement for renal replacement therapy
    9) Patient has renal insufficiency as evidenced by an estimated creatinine clearance <50 mL/min based on the Cockcroft-Gault formula
    10) Patient has comorbidities influencing vancomycin pharmacokinetics as the following
      ① myeloma
      ② cystic fibrosis or active pulmonary tuberculosis
      ③ lung transplant recipient or donor
      ④ burn injury on more than 20 % of the body surface
    11) Any other major illness that, in the investigator's judgment, may interfere with the study objectives.
    12) Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation/completion in this study.
    13) Any other factor that, in the investigator's judgment, inappropriate to participate in this study.
    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/dynamics
    Primary Outcome(s) 1
    Outcome
    C_max of vancomycin
    Timepoint
    Day 1
    Primary Outcome(s) 2
    Outcome
    C_trough of vancomycin
    Timepoint
    Day 1, Day 1~7 (when TDM)
    Primary Outcome(s) 3
    Outcome
    AUC_tau of vancomycin
    Timepoint
    Day 1
    Primary Outcome(s) 4
    Outcome
    C_ELF of vancomycin
    Timepoint
    Day 1, Day 2~7 (when BAL)
    Secondary Outcome(s) 1
    Outcome
    Plasma biomarkers of nephrotoxicity
    Timepoint
    Day 1~7
    Secondary Outcome(s) 2
    Outcome
    Urinary biomarkers of nephrotoxicity
    Timepoint
    Day 1, Day 4
  • 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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