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.
|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|
- 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 ]
- Adverse event rate in each arm, including nephrotoxicity and rash. [ Time Frame: 7 days post-treatment ] [ Designated as safety issue: Yes ]
|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)|
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.
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.
|Contact: Kyong Ran Peck, MDfirstname.lastname@example.org|
|Contact: So Yeon Park, MDemail@example.com|
|Korea, Republic of|
|Samsung Medical Center||Not yet recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Kyong Ran Peck, MD +82-2-3410-0322 firstname.lastname@example.org|
|Contact: So Yeon Park, MD +82-3410-0329 email@example.com|
|Principal Investigator: Kyong Ran Peck, MD|
|Sub-Investigator: So Yeon Park, MD|
|Principal Investigator:||Kyong Ran Peck, MD||Samsung Medical Center|