Effectiveness of Vancomycin Loading Therapy

Not Applicable

Completed

• Conditions: Infection
• Interventions: Drug: Vancomycin HCL

• Registration Number: NCT01623817
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin loading	Vancomycin HCL	This group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse event rate in each arm, including nephrotoxicity and rash.	7 days post-treatment

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of