Status:
COMPLETED
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)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Infection Resistant to Multiple Drugs
Eligibility:
All Genders
18+ years
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...
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 inhal...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01894347
Start Date
September 1 2013
End Date
December 1 2015
Last Update
August 3 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité Universitätsmedizin Charité
Berlin, State of Berlin, Germany, 13353