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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
-
Berlin、ドイツ、13353
- Charité Universitätsmedizin Charité
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number and frequency of adverse events (nephro- or neurotoxicity after aerosolised colistin therapy)
時間枠：28 days
|
Adverse events are measured based on validated criteria:
|
28 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum concentration of colistin and β-Lactam antibiotics
時間枠：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
|
3 days
|
|
Serum levels of colistin and β-Lactam antibiotics (e.g. Meropenem)in mg/L
時間枠：3 days
|
Serum drug levels in mg/L 2hours, 8 hours and 3 days (steady state) after therapy induction
|
3 days
|
協力者と研究者
捜査官
- 主任研究者：Maria Deja, Prof.、Charité Universititaetsmedizin Berlin
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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