Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
Primary Purpose
Respiratory Tract Diseases, Nosocomial Infections
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
antibiotic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Diseases focused on measuring ventilator-associated tracheobronchitis, nosocomial tracheobronchitis
Eligibility Criteria
Inclusion Criteria: Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation Exclusion Criteria: Immunodepressed patients Patients with tracheostomy at ICU admission Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis
Sites / Locations
- 12 ICUs in north of France
Outcomes
Primary Outcome Measures
duration of mechanical ventilation
Secondary Outcome Measures
length of intensive care unit (ICU) stay
mortality rate
ventilator-associated pneumonia rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00122057
Brief Title
Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Lille
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical ventilation.
Detailed Description
Rationale:
Ventilator-associated tracheobronchitis (VAT) is common in intensive care unit (ICU) patients, rates of 2.7%-10.6% are reported in the literature. This nosocomial infection is associated with weaning difficulties resulting in prolonged duration of mechanical ventilation (MV) and ICU stay. A case-control study performed in chronic obstructive pulmonary disease (COPD) patients with VAT found antibiotic treatment to be significantly associated with reduced duration of MV. Another case control-study, performed in VAT patients without chronic respiratory failure, found no significant difference in duration of MV between patients who received adequate antibiotic treatment and those who received inadequate antibiotic treatment. In addition, antibiotic use is known to be associated with subsequent multidrug-resistant bacteria (MRB), longer duration of MV, and mortality rates. Therefore, a randomized controlled study is necessary to determine the impact of antibiotic treatment on outcome in VAT patients.
Patients and methods:
390 patients will be included in this prospective randomized open multicenter study. Inclusion of 390 patients is required to demonstrate a significant reduction of MV duration of 5 days (α = 0.025, β = 0.10). An intermediate analysis will be performed. All patients intubated and ventilated > 48h who developed a first episode of VAT are eligible. Primary endpoint is the duration of MV. Secondary end points are ICU length of stay, mortality, ventilator-associated pneumonia, ICU-acquired infection, MRB, and yeast rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases, Nosocomial Infections
Keywords
ventilator-associated tracheobronchitis, nosocomial tracheobronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
antibiotic treatment
Primary Outcome Measure Information:
Title
duration of mechanical ventilation
Secondary Outcome Measure Information:
Title
length of intensive care unit (ICU) stay
Title
mortality rate
Title
ventilator-associated pneumonia rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation
Exclusion Criteria:
Immunodepressed patients
Patients with tracheostomy at ICU admission
Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Nseir, MD
Organizational Affiliation
University Hospital of Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
12 ICUs in north of France
City
Lille
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18454864
Citation
Nseir S, Favory R, Jozefowicz E, Decamps F, Dewavrin F, Brunin G, Di Pompeo C, Mathieu D, Durocher A; VAT Study Group. Antimicrobial treatment for ventilator-associated tracheobronchitis: a randomized, controlled, multicenter study. Crit Care. 2008;12(3):R62. doi: 10.1186/cc6890. Epub 2008 May 2.
Results Reference
derived
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Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
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