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临床试验/NCT00617227
NCT00617227已完成不适用

Measurement of Serum Vancomycin in Patients Receiving Enteral ( Oral/Intracolonic) Vancomycin.

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Patients with detectable serum vancomycin levels during enteral vancomycin therapy

研究概览

简要总结

The study is based on the hypothesis that decreased creatinine clearance may be associated with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas) vancomyicn for CDAD.

The objective of the study is to see whether enteral vancomycin is absorbed through the inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum concentration.

详细描述

Vancomycin is a large glycopeptide compound with a molecular weight of about 1450 Da. It is not appreciably absorbed orally and is eliminated primarily via the renal route. Enteral vancomycin therapy (oral/intracolonic ) is used inpatients with severe Clostridium difficile associated colitis who are unable to take oral metronidazole or have failed treatment with metronidazole. Oral vancomycin is not detectable in serum of normal persons, but concentrations below therapeutic range may be found in patients with colitis. There are a few case reports of serum concentrations within the therapeutic range after oral/intracolonic administration of vancomycin, in association with renal failure. The use of enteral vancomycin in our geriatric population with variable creatinine clearance prompted us to measure the serum vancomycin levels in these patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients on enteral vancomycin therapy

排除标准

  • Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.

结局指标

主要结局

Patients with detectable serum vancomycin levels during enteral vancomycin therapy

时间窗: 5-7days

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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