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)

NCT01894347 | Completed

• 1 other identifier: LOKALE
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection Resistant to Multiple Drugs

Keywords

Colistin, MDR, inhalative therapy

Outcome Measures

Primary Outcomes (1)

• Number and frequency of adverse events (nephro- or neurotoxicity after aerosolised colistin therapy)

  Adverse events are measured based on validated criteria: 1. creatinine-clearance and RIFLE-criteria 2. Neuromonitoring (nerve conduction velocity, EEG)

  28 days

Secondary Outcomes (2)

• Serum concentration of colistin and β-Lactam antibiotics

  3 days

• Serum levels of colistin and β-Lactam antibiotics (e.g. Meropenem)in mg/L

  3 days

Study Arms (1)

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

Interventions

TDM, Monitoring of Neuro-and Nephropathology OTHER

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

Colistin inhalative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Charité

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (4)

• 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.

  PMID: 19118994 BACKGROUND

• 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.

  PMID: 19438398 BACKGROUND

• 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.

  PMID: 20818945 BACKGROUND

• 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.

  PMID: 10903263 BACKGROUND

Related Links

• This study initiative is launched by the ABx study group.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tracheal aspirates

Study Officials

• Maria Deja, Prof.

  Charité Universititaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Maria Deja

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 10, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

DE (1)