Effectiveness of Vancomycin Loading Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01623817|
Recruitment Status : Unknown
Verified June 2012 by Samsung Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 20, 2012
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: Vancomycin HCL||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Vancomycin Loading Therapy|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
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.
- 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. ]
- Adverse event rate in each arm, including nephrotoxicity and rash. [ Time Frame: 7 days post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623817
|Contact: Kyong Ran Peck, MDemail@example.com|
|Contact: So Yeon Park, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Not yet recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Kyong Ran Peck, MD +82-2-3410-0322 email@example.com|
|Contact: So Yeon Park, MD +82-3410-0329 firstname.lastname@example.org|
|Principal Investigator: Kyong Ran Peck, MD|
|Sub-Investigator: So Yeon Park, MD|
|Principal Investigator:||Kyong Ran Peck, MD||Samsung Medical Center|