Effectiveness of Vancomycin Loading Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Samsung Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01623817
First received: June 18, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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
Infection
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.
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623817

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

Locations
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
Investigators
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:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014