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Effectiveness of Vancomycin Loading Therapy

Effectiveness of Vancomycin Loading Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01623817
Enrollment
20
Registered
2012-06-20
Start date
2012-06-30
Completion date
2012-12-31
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

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.

Interventions

DRUGVancomycin 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time duration for concentration of vancomycin to reach target trough of 15-20 mg/LPeak 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

MeasureTime frame
Adverse event rate in each arm, including nephrotoxicity and rash.7 days post-treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026