Effectiveness of Vancomycin Loading Therapy
Recruitment status was Not yet recruiting
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623817
|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|