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
CRIS Registration Number |
KCT0006018 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
Project ID | KNUH-2021-02-003-001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
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 |
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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)
Type of Primary Outcome | Pharmacokinetics | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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