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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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22 April 2021 |
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Main ID: |
KCT0006018 |
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Date of registration:
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2021-03-24 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An exploratory clinical trial for optimizing vancomycin therapy in Korean patients with MRSA infection
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Scientific title:
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An exploratory clinical trial to evaluate the clinical benefit of AUC-based vancomycin TDM in Korean patients with MRSA infection |
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Date of first enrolment:
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2021-03-22 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=19053 |
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Study type:
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Observational Study |
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Study design:
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Observational Study Model : Cohort, Time Perspective : Prospective, Enrollment : 80, Biospecimen Retention : Collect & Archive- Sample without DNA, Biospecimen Description : Urine
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Phase:
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NA
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sang-In
Park |
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Address:
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156, Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
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Telephone:
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+82-33-250-8851 |
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Email:
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sibach27@gmail.com |
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Affiliation:
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Kangwon National University |
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Name:
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Ji In
Park |
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Address:
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156, Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
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Telephone:
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+82-33-258-9204 |
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Email:
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park.jiin@gmail.com |
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Affiliation:
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Kangwon National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: ? Patients who have the ability to sign the consent form in accordance with GCP and corresponding laws
? Patients who are 19 years or older
? 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
? Patient who understands the contents of the clinical research and provide their written informed consent forms
Exclusion criteria: ? Patients who co-administered vancomycin, except for the intravenous route. (e.g., per oral)
? Patients with contraindications for vancomycin (e.g., Anaphylaxis due to vancomycin)
? Patients in pregnancy or lactation
? Patients whom the researcher deemed inappropriate for clinical research participation
Age minimum:
19(Year)
Age maximum:
0No Limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Certain infectious and parasitic diseases
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Primary Outcome(s)
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Pharmacokinetic parameters (AUC, Ctrough)
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Secondary Outcome(s)
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Occurrence of nephrotoxicity
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Source(s) of Monetary Support
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Kangwon National University Hospital
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Ethics review
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Status: Submitted approval
Approval date: 05/03/2021
Contact:
Kangwon National University Hospital Institutional Review Board
+82-33-258-9199
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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