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

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ClinicalTrials.gov Identifier: NCT00122057
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : June 1, 2011
Sponsor:
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:

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.


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
U.S. FDA Resources




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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00122057


Locations
France
12 ICUs in north of France
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Saad Nseir, MD University Hospital of Lille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00122057     History of Changes
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:
Respiratory Tract Diseases
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents