CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
TDM, Monitoring of Neuro-and Nephropathologyother
Likely dose
Not stated in record
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Search/NCT01894347
NCT01894347N/ACompleted
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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)

Charite University, Berlin, Germany·observational·Posted Jul 10, 2013·Updated Aug 3, 2016

In Brief

An observational study evaluating TDM, Monitoring of Neuro-and Nephropathology for Infection Resistant to Multiple Drugs. Completed, enrolled 9 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfection Resistant to Multiple Drugs
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 10, 2013
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.0 years ago

Interventions

TDM, Monitoring of Neuro-and Nephropathologyother

Therapeutic drug monitoring of serum levels and Monitoring of Neuro- and Nephropathology