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)

August 2, 2016 updated by: Maria Deja, Charite University, Berlin, Germany

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients with invasive ventilation and colonization or infection with MDR pathogens

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colistin inhalative

Adult ICU patients with

  • invasive ventilation 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. creatinine-clearance and RIFLE-criteria
  2. Neuromonitoring (nerve conduction velocity, EEG)
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Maria Deja, Prof., Charité Universititaetsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOKALE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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