Effectiveness of Vancomycin Loading Therapy

This study is not yet open for participant recruitment.
Verified June 2012 by Samsung Medical Center
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

June 18, 2012
June 19, 2012
June 2012
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01623817 on ClinicalTrials.gov Archive Site
Adverse event rate in each arm, including nephrotoxicity and rash. [ Time Frame: 7 days post-treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Vancomycin Loading Therapy
Effectiveness of Vancomycin Loading Therapy

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Infection
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.
  • 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.
    Intervention: Drug: Vancomycin HCL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
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
 
NCT01623817
2011-09-067
Yes
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Kyong Ran Peck, MD Samsung Medical Center
Samsung Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP