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临床试验/NCT02033421
NCT02033421Unknown不适用

Beta-lactam Pharmacokinetic Profiles in Patients With Infective Endocarditis

University of Aarhus1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Blood-plasma concentration of Beta-lactam antibiotics

研究概览

简要总结

The recommended length of antibiotic treatment to patients with infective endocarditis is 4-6 weeks. All patients receive the same dosis except for those with renal impairment who receive a smaller dose. For Beta-lactam antibiotics, a plasma concentration above the minimal inhibitory concentration (MIC) for at least 50% of the time in a dosing interval maximize bactericidal activity. To estimate the time for which the antibiotic concentration is above the MIC (T>MIC) and to see if there might be a relationship between the concentration of antibiotics and possible side-effects, toxicity and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

详细描述

Comorbidity is common in patients admitted with infective endocarditis and this may effect the pharmacokinetics of antibiotics. The same dose of antibiotics may therefore result in different plasma concentrations in different patients, and this might influence possible side-effects, toxicity and treatment failure.

To investigate this further, all patients admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks. Beta-lactam is administered every 6th hour. The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion. There is no intervention in the study, the results are observational. The results will contribute to assess the efficacy and quality of the treatment and help evaluate whether plasma concentration of antibiotics should be taken as a routine blood test every week in patients with infective endocarditis.

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 admitted with infective endocarditis
  • Treatment with Beta-lactam antibiotics

排除标准

  • Under 18 years of age

结局指标

主要结局

Blood-plasma concentration of Beta-lactam antibiotics

时间窗: Once a week during antibiotic treatment, an expected average of 5 weeks

The first blood test will be withdrawn within a week after initiation of antibiotic therapy. The next blood test will be taken approximately 7 days after the first one and so forth once a week, until the termination of antibiotic treatment, an expected average of 5 weeks.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Öbrink-Hansen

MD, ph.d.-student

University of Aarhus

研究点 (1)

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