Effectiveness of Vancomycin Loading Therapy

Infection Clinical Trial

Official title:

Effectiveness of Vancomycin Loading Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623817
• Other study ID #: 2011-09-067
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse event rate in each arm, including nephrotoxicity and rash.		7 days post-treatment