Tracheobronchitis Prevention Trial (TRAMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Efstratios Manoulakas, University of Thessaly
ClinicalTrials.gov Identifier:
NCT01025921
First received: December 3, 2009
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Tracheobronchitis
Pneumonia
Drug: colistin (Tadim)
Other: inhaled normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Inhaled Antibiotics for Prevention of Tracheobronchitis and Ventilator Associated Pneumonia

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Incidence of tracheobronchitis and ventilator associated pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilator free days and ICU length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: November 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inhaled colistin
They will receive inhaled colistin three times daily for 10 days.
Drug: colistin (Tadim)
500.000 units of inhaled colistin three times daily for 10 days
Placebo Comparator: Inhaled normal saline
Inhaled normal saline three times daily for 10 days
Other: inhaled normal saline
inhalation of 2,5cc Normal Saline via nebulisation

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:

  1. The incidence of VAP The incidence of VAT
  2. Mechanical ventilation free days
  3. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025921

Locations
Greece
University Hospital of Larissa
Larissa, Greece, 41110
Sponsors and Collaborators
University of Thessaly
  More Information

No publications provided

Responsible Party: Efstratios Manoulakas, Professor and ICU Director Zakynthinos Epaminondas, University of Thessaly
ClinicalTrials.gov Identifier: NCT01025921     History of Changes
Other Study ID Numbers: MARKAR161109
Study First Received: December 3, 2009
Last Updated: May 31, 2013
Health Authority: Hellenic Ministry of Health: Greece:

Keywords provided by University of Thessaly:
Tracheobronchitis
pneumonia
inhaled antibiotics
colistin
Ventilator associated tracheobronchitis
Ventilator associated pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Anti-Bacterial Agents
Colistin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014