Tracheobronchitis Prevention Trial (TRAMA)
Primary Purpose
Tracheobronchitis, Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
colistin (Tadim)
inhaled normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Tracheobronchitis focused on measuring Tracheobronchitis, pneumonia, inhaled antibiotics, colistin, Ventilator associated tracheobronchitis, Ventilator associated pneumonia
Eligibility Criteria
Inclusion Criteria:
- All intubated and tracheostomized patients, older than 18 years old with duration of intubation of 48 hours.
Exclusion Criteria:
- Purulent sputum within 48 hours from admission
- Pneumonia within 48 hours of intubation
- New chest X ray infiltrate
- Advanced COPD that led to intubation
- Pregnancy
- Allergy to colistin
- Resistance of the bacterial strain to colistin
Sites / Locations
- University Hospital of Larissa
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
Inhaled colistin
Inhaled normal saline
Arm Description
They will receive inhaled colistin three times daily for 10 days.
Inhaled normal saline three times daily for 10 days
Outcomes
Primary Outcome Measures
Incidence of tracheobronchitis and ventilator associated pneumonia
Secondary Outcome Measures
Ventilator free days and ICU length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01025921
Brief Title
Tracheobronchitis Prevention Trial
Acronym
TRAMA
Official Title
Study of Inhaled Antibiotics for Prevention of Tracheobronchitis and Ventilator Associated Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.
Detailed Description
INTRODUCTION Gram-negative bacteria have recently become endemic in many ICUs around the world. Ventilator associated pneumonia (VAP) is relatively common and its parenteral treatment often leads to low and sub-therapeutic concentrations of antibiotics in the lung. Ventilator associated tracheobronchitis (VAT) is characterized by fever, purulent sputum, positive cultures of tracheal aspirates secretions and the absence of new pulmonary infiltrates on CXR. This entity is of particular interest because it is an intermediate step in the pathogenesis of VAP (between colonization and VAP itself) and prolongs mechanical ventilatory support. Inhaled antibiotics achieve high (both peak and trough) concentrations in respiratory secretions. Endobronchial antibiotics have been given to non-cystic fibrosis patients for prevention of VAP. Colistimethate sodium (colistin) given by instillation decreased the incidence of Gram-negative pneumonia and did not lead to the development of colistin resistant bacteria.
AIM
The study is a prospective open label randomized study which aims to clarify the effect of colistin to:
The incidence of VAP The incidence of VAT
Mechanical ventilation free days
Incidence of multidrug resistant bacteria in tracheal aspirates cultures
METHODS Settings: The study will be performed in the ICU of the University of Larissa (12 beds).
Entry criteria: All intubated and tracheostomised patients, older than 18 years old with duration of intubation of 48 hours.
Exclusion criteria: 1) Purulent sputum within 48 hours from admission. 2) Pneumonia within 48 hours of intubation 3) New chest X ray infiltrate, 4) Advanced COPD that led to intubation 5) Pregnancy 6) Allergy to colistin 7) Resistance of the bacterial strain to colistin.
Tools: Randomization of the patients into two groups: the first group will receive nebulized colistin and the other no treatment. The initial dose is 1000000 units and it will be doubled after measurement of the drug concentration in tracheal secretions. The drug will start on admission and stop after 10 days.
All patients will be given the respiratory bundle measures (semi-recumbent position, daily interruption of sedation) as part of the usual daily practice of our ICU except otherwise indicated.
The severity of patients will be estimated by APACHE II score on admission and SOFA score thrice weekly. CPIS score as a screening tool for pneumonia will be estimated as well thrice weekly.
Tracheal aspirates cultures on admission and thrice weekly thereafter for the first two weeks and twice weekly thereafter.
The patients will be followed for thirty days to measure outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheobronchitis, Pneumonia
Keywords
Tracheobronchitis, pneumonia, inhaled antibiotics, colistin, Ventilator associated tracheobronchitis, Ventilator associated pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled colistin
Arm Type
Placebo Comparator
Arm Description
They will receive inhaled colistin three times daily for 10 days.
Arm Title
Inhaled normal saline
Arm Type
Placebo Comparator
Arm Description
Inhaled normal saline three times daily for 10 days
Intervention Type
Drug
Intervention Name(s)
colistin (Tadim)
Intervention Description
500.000 units of inhaled colistin three times daily for 10 days
Intervention Type
Other
Intervention Name(s)
inhaled normal saline
Intervention Description
inhalation of 2,5cc Normal Saline via nebulisation
Primary Outcome Measure Information:
Title
Incidence of tracheobronchitis and ventilator associated pneumonia
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Ventilator free days and ICU length of stay
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All intubated and tracheostomized patients, older than 18 years old with duration of intubation of 48 hours.
Exclusion Criteria:
Purulent sputum within 48 hours from admission
Pneumonia within 48 hours of intubation
New chest X ray infiltrate
Advanced COPD that led to intubation
Pregnancy
Allergy to colistin
Resistance of the bacterial strain to colistin
Facility Information:
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
12. IPD Sharing Statement
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Tracheobronchitis Prevention Trial
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