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Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis

2015年11月6日更新者：Kristina Öbrink-Hansen、University of Aarhus

At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).

It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.

研究概览

地位

完全的

条件

囊性纤维化

详细说明

Patients with cystic fibrosis (CF) are often colonized with multidrug-resistant microorganisms, which increases the risk of suboptimal dosing of antibiotics as the time above the minimum inhibitory concentration (T>MIC) is suboptimal. Continuous infusion of beta-lactam antibiotics is more likely to optimize T>MIC than intermittent infusion. At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with CF, suffering from acute pulmonary exacerbations (APE). It is an outpatient treatment, and the patients are given 16 g of piperacillin per 24 hours. To assess the efficacy and quality of the treatment, a blood test every 3rd day will be required to monitor the blood-plasma concentration of piperacillin, as well as C-reactive protein (CRP) and white blood cell count (WBC).

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

丹麦
- Aarhus N
  - Aarhus、Aarhus N、丹麦、8220
    - Department of Infectious Diseases, Aarhus University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations.

描述

Inclusion Criteria:

Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations, treated with continuous infusion of Piperacillin/Tazobactam for a period of two weeks.

Exclusion Criteria:

Age under 18

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Pharmacokinetics Piperacillin Patients with cystic fibrosis , treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Blood-plasma Concentration of Piperacillin 大体时间：Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment	The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment. Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment.	Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment

次要结果测量

结果测量	措施说明	大体时间
The Time Above the Minimum Inhibitory Concentration (T>MIC) 大体时间：Patients will be followed for the duration of treatment, which is approximately 2 weeks.	The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated. Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day.	Patients will be followed for the duration of treatment, which is approximately 2 weeks.
MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment. 大体时间：Sputum sample was collected 3 to 7 days before treatment initiation.	MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.	Sputum sample was collected 3 to 7 days before treatment initiation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Aarhus

调查人员

研究主任：Eskild Petersen, Professor、Department of Infectious Diseases, Aarhus University Hospital, Denmark

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年7月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2013年7月11日

首先提交符合 QC 标准的

2013年11月7日

首次发布 (估计)

2013年11月14日

研究记录更新

最后更新发布 (估计)

2015年12月11日

上次提交的符合 QC 标准的更新

2015年11月6日

最后验证

2015年11月1日