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)
|ClinicalTrials.gov Identifier: NCT01894347|
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : August 3, 2016
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.
|Condition or disease||Intervention/treatment|
|Infection Resistant to Multiple Drugs||Other: TDM, Monitoring of Neuro-and Nephropathology|
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.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||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)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||December 2015|
Adult ICU patients with
Patients included into the study group receive additional TDM, Monitoring of Neuro-and Nephropathology
Other: TDM, Monitoring of Neuro-and Nephropathology
Therapeutic drug monitoring of serum levels and Monitoring of Neuro- and Nephropathology
- Number and frequency of adverse events (nephro- or neurotoxicity after aerosolised colistin therapy) [ Time Frame: 28 days ]
Adverse events are measured based on validated criteria:
- creatinine-clearance and RIFLE-criteria
- Neuromonitoring (nerve conduction velocity, EEG)
- Serum concentration of colistin and β-Lactam antibiotics [ Time Frame: 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
- Serum levels of colistin and β-Lactam antibiotics (e.g. Meropenem)in mg/L [ Time Frame: 3 days ]Serum drug levels in mg/L 2hours, 8 hours and 3 days (steady state) after therapy induction
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894347
|Charité Universitätsmedizin Charité|
|Berlin, Germany, 13353|
|Principal Investigator:||Maria Deja, Prof.||Charité Universititaetsmedizin Berlin|