Effectiveness of Vancomycin Loading Therapy

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 Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Drug: Vancomycin HCL

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: The brand name is the Vancomycin hydrochloride.; It is made by Lilly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Kyong Ran Peck, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 2011-09-067