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Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00122057
First received: July 14, 2005
Last updated: May 31, 2011
Last verified: September 2006

July 14, 2005
May 31, 2011
June 2005
May 2007   (final data collection date for primary outcome measure)
duration of mechanical ventilation
Same as current
Complete list of historical versions of study NCT00122057 on ClinicalTrials.gov Archive Site
  • length of intensive care unit (ICU) stay
  • mortality rate
  • ventilator-associated pneumonia rate
  • length of ICU stay
  • mortality rate
  • ventilator-associated pneumonia rate
Not Provided
Not Provided
 
Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Tract Diseases
  • Nosocomial Infections
Drug: antibiotic treatment
Not Provided
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. Epub 2008 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
June 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122057
2005/0506
Not Provided
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Saad Nseir, MD University Hospital of Lille
University Hospital, Lille
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP