Prospective Observational Pilot-study for the Evaluation of the Nephro- an Neurotoxicity in the Anti-infectious Therapy With Inhalative Colistin Therapy for Patients With Ventilator-associated Pneumonia (VAP) (LOKALE)
Multi-Drug resistant pathogens (MDR) are reported worldwide with increasing incidence, especially in intensive care settings.
One of the drugs which are effective against MDRs, is colistin (polymyxin E). This agent has been reintroduced in response to the increase of MDR pathogens and might be used more often in the future. Data on safety regarding the most important side effects are not sufficiently available. l This study evaluates the toxicity in patients who receive aerosolized colistin.
研究概览
详细说明
There is growing evidence that patients in the ICU setting have a special risk profile for consecutive colonization and possible infection due to MDR pathogens.
One therapy option is the use of inhalative colistin, as this agent has been demonstrated to be effective against these pathogens. Data on pharmacodynamics or - kinetics are transferred from older studies or from other patient populations. For patients with pulmonary colonization or infection due to an MDR pathogen the systemic resorption of the drug is not known, consequently systemic side effects including kidney or neural damage are not predictable.
This study focus on patients with inhalative colistin therapy and uses therapeutic drug monitoring to determine the rate of systemic resorption of colistin. For the evaluation of neurotoxicity function of peripheral nerves (neve conduction velocity) and of the eighth cranial nerve is monitored. Nephrotoxicity is estimated by creatinine level (-clearance) and the RIFLE criteria.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Berlin、德国、13353
- Charité Universitätsmedizin Charité
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion criteria:
- invasive ventilated patients (male and female) with assumed or assured bacteria with an elevated resistance pattern found in a tracheal or bronchial secretion with or without clinical signs of infection
- indicated colistin co-therapy or eradication-attempt with inhalative colistin (β-Lactam) therapy according to the standard operation procedure (SOP) of the hospital
Exclusion criteria:
- Consent of the patient or of the patient´s legal representative can´t be obtained soon
- Age < 18 years
- Included within another, prospective clinical antibiotics-study
- Hypersensitivity to colistin or polymyxin B
- Patients with cystic fibrosis
- Present letter of attorney or patient´s provision, which precludes a priori the participation in studies
- Missing consent for storage of pseudonymised data in context of the study
- The patient is in an institution due to a court injunction or administrative order
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Colistin inhalative
Adult ICU patients with
Patients included into the study group receive additional TDM, Monitoring of Neuro-and Nephropathology |
Therapeutic drug monitoring of serum levels and Monitoring of Neuro- and Nephropathology
|
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 |
|---|---|---|
|
Number and frequency of adverse events (nephro- or neurotoxicity after aerosolised colistin therapy)
大体时间：28 days
|
Adverse events are measured based on validated criteria:
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28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum concentration of colistin and β-Lactam antibiotics
大体时间：3 days
|
Colistin-concentration in serum following inhalative therapy (in mg/L) 2 hours and 8 hours of application and in steady state on day 3 of therapy
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3 days
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Serum levels of colistin and β-Lactam antibiotics (e.g. Meropenem)in mg/L
大体时间：3 days
|
Serum drug levels in mg/L 2hours, 8 hours and 3 days (steady state) after therapy induction
|
3 days
|
合作者和调查者
调查人员
- 首席研究员：Maria Deja, Prof.、Charité Universititaetsmedizin Berlin
出版物和有用的链接
一般刊物
- Falagas ME, Siempos II, Rafailidis PI, Korbila IP, Ioannidou E, Michalopoulos A. Inhaled colistin as monotherapy for multidrug-resistant gram (-) nosocomial pneumonia: a case series. Respir Med. 2009 May;103(5):707-13. doi: 10.1016/j.rmed.2008.11.018. Epub 2008 Dec 31.
- Falagas ME, Rafailidis PI. Nephrotoxicity of colistin: new insight into an old antibiotic. Clin Infect Dis. 2009 Jun 15;48(12):1729-31. doi: 10.1086/599226. No abstract available.
- Michalopoulos AS, Karatza DC. Multidrug-resistant Gram-negative infections: the use of colistin. Expert Rev Anti Infect Ther. 2010 Sep;8(9):1009-17. doi: 10.1586/eri.10.88.
- Hamer DH. Treatment of nosocomial pneumonia and tracheobronchitis caused by multidrug-resistant Pseudomonas aeruginosa with aerosolized colistin. Am J Respir Crit Care Med. 2000 Jul;162(1):328-30. doi: 10.1164/ajrccm.162.1.9910071.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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