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OpenTrials
Completed

NCT Number: NCT01623817

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.

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Key information

Conditions

Infection Infections

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin HCL

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. Adverse event rate in each arm, including nephrotoxicity and rash.

    Time frame: 7 days post-treatment

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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