Effectiveness of Vancomycin Loading Therapy

This study is not yet open for participant recruitment.
Verified June 2012 by Samsung Medical Center
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
First received: June 18, 2012
Last updated: June 19, 2012
Last verified: June 2012

The goal of tish clinical research study is to identify that loading of vancomycin can faciliate rapid attainment of target trough serum vancomycin concentration.

Condition Intervention
Drug: Vancomycin HCL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Vancomycin Loading Therapy

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L [ Time Frame: Peak level drawn 1 hour after the completion of loading dose. Sequential trough level drawn 30 min before each standard dose for the next 4 doses. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse event rate in each arm, including nephrotoxicity and rash. [ Time Frame: 7 days post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Vancomcyin
This arm is received only maintaind dose of vancomycin (15mg/kg twice a day or 1g twice a day).
Experimental: Vancomycin loading
This group is recived loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care.
Drug: Vancomycin HCL

Loading dose of 30mg/kg via central or peripheral intraveous infusion during 2 or 3 hours.

Maintanance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.

Other Names:
  • The brand name is the Vancomycin hydrochloride.
  • It is made by Lilly.

Detailed Description:

The Study drug

  • Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant stapylococcus aureus

Study design : Randomized controlled trials

Study Drug Administration

  • If your doctor believes you are eligible, and you agree to take part in thish study, you will be randomized to two treatment groups.

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
  • Patients with SIRS (systemic inflammatory response syndrome)
  • Intravenous vancomycin therapy deemed necessary

Exclusion Criteria:

  • Age less than 20 years
  • Age more than 75 years
  • Current renal insufficiency defined as estimated Glomerular filtration rate < 50mg/min/1.73 m2 by MDRD equation
  • History of adverse events to vancomycin 5. Pregant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623817

Contact: Kyong Ran Peck, MD +82-2-3410-0322 krpeck@skku.edu
Contact: So Yeon Park, MD +80-2-3410-0329 miunori26@hanmail.net

Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyong Ran Peck, MD    +82-2-3410-0322    krpeck@skku.edu   
Contact: So Yeon Park, MD    +82-3410-0329    miunori26@hanmail.net   
Principal Investigator: Kyong Ran Peck, MD         
Sub-Investigator: So Yeon Park, MD         
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Kyong Ran Peck, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01623817     History of Changes
Other Study ID Numbers: 2011-09-067
Study First Received: June 18, 2012
Last Updated: June 19, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014