Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122057
Status:
COMPLETED
Last Update Posted:
2011-06-01
First Post:
2005-07-14
Brief Title:
Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 27-106 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 0025 β 010 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
Ventilator-associated tracheobronchitis VAT is common in intensive care unit ICU patients rates of 27-106 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 0025 β 010 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None