Effectiveness of Vancomycin Loading Therapy

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2012

Detailed Description

The Study drug – Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant staphylococcus aureus Study design : Randomized controlled trials Study Drug Administration – If your doctor believes you are eligible, and you agree to take part in this study, you will be randomized to two treatment groups.

Interventions

  • Drug: Vancomycin HCL
    • Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours. Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.

Arms, Groups and Cohorts

  • No Intervention: Vancomcyin, maintain dose
    • This arm is received only maintain dose of vancomycin (15mg/kg twice a day or 1g twice a day).
  • Experimental: Vancomycin loading
    • This group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care.

Clinical Trial Outcome Measures

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.

Secondary Measures

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

Participating 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. Pregnant woman

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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

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