Brief Summary

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Official Title: "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 Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Study Primary Completion Date: December 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.

Outcome Measures for this Clinical Trial

Primary 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.
    Safety Issue?: Yes

Secondary Measures

• Adverse event rate in each arm, including nephrotoxicity and rash.
  • Time Frame: 7 days post-treatment
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Samsung Medical Center
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Kyong Ran Peck, MD, Principal Investigator, Samsung Medical Center
• Overall Contact(s)
  • Kyong Ran Peck, MD, +82-2-3410-0322, krpeck@skku.edu