跳至主要内容
临床试验/NCT01623817
NCT01623817已完成不适用

Effectiveness of Vancomycin Loading Therapy

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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
  • •Pregnant woman

研究组 & 干预措施

Vancomycin loading

Experimental

This group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care.

干预措施: Vancomycin HCL (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Adverse event rate in each arm, including nephrotoxicity and rash.(7 days post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验