Overview
Nebulized Colistin for Gram Negative VAP Prevention.
Status:
Recruiting
Recruiting
Trial end date:
2021-09-01
2021-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Colistin is used as an elective treatment of infections of multi drug resistant gram negative bacteria. Until now colistin is used in the therapeutic regimen of these infections intravenous or nebulized. There are a plenty of studies about the efficacy of nebulized colistin in the therapy of pseudomonas aeruginosa pneumonia in patients with cystic fibrosis and in the therapy of ventilator associated pneumonia in ICU. On the other hand there are only a few studies about the use of nebulized colistin in the prevention of ventilator associated pneumonia whereas the role of nebulized colistin in the prevention of severe forms of pneumonia such as VAP due to multi drug resistant gram negative bacteria are limited. This double blinded randomized trial aim to investigate the effect of nebulized colistin on the incidence of patients with due to gram negative bacteria in the ICU compared to nebulized normal saline.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of ThessalyTreatments:
Colistin
Criteria
All patients undergoing invasive mechanical ventilation through an endotracheal tube ortracheostomy will be considered for inclusion and recorded on a screening log. Patients
will be assessed for eligibility within the first 48h of invasive ventilation.
Inclusion criteria
1. - Age ≥ 18 years the day of inclusion
2. - Mechanical ventilation through an endotracheal tube > 48h
3. - Written informed consent of patient or proxy Exclusion criteria
1. Community acquired pneumonia or other nosocomial pneumonia or tracheobronchitis 2. Known
colistin resistant bacteria in tracheo-bronchial aspirate's culture 3. Known allergy to
colistin 4. Patient scheduled for extubation within the next 24h 5. Patient mechanically
ventilated > 96h 6. Known or suspicion of pregnancy at the time of inclusion 7. Pregnant or
breastfeeding women 8. Participation in other studies with inhaled or systemic antibiotics
or in other VAP related studies.