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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122057
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : June 1, 2011
Information provided by:
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Diseases Nosocomial Infections Drug: antibiotic treatment Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Primary Outcome Measures :
  1. duration of mechanical ventilation

Secondary Outcome Measures :
  1. length of intensive care unit (ICU) stay
  2. mortality rate
  3. ventilator-associated pneumonia rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00122057

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12 ICUs in north of France
Lille, France
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Saad Nseir, MD University Hospital of Lille
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Lille Identifier: NCT00122057    
Other Study ID Numbers: 2005/0506
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: September 2006
Keywords provided by University Hospital, Lille:
ventilator-associated tracheobronchitis
nosocomial tracheobronchitis
Additional relevant MeSH terms:
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Cross Infection
Respiratory Tract Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents