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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2005

Last Updated Date

May 31, 2011

Start Date ^ICMJE

June 2005

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

duration of mechanical ventilation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00122057 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

length of intensive care unit (ICU) stay
mortality rate
ventilator-associated pneumonia rate

Original Secondary Outcome Measures ^ICMJE

length of ICU stay
mortality rate
ventilator-associated pneumonia rate

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Respiratory Tract Diseases
Nosocomial Infections

Intervention ^ICMJE

Drug: antibiotic treatment

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00122057

Other Study ID Numbers ^ICMJE

2005/0506

Has Data Monitoring Committee

Not Provided

Responsible Party

University Hospital, Lille

Study Sponsor ^ICMJE

University Hospital, Lille

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Saad Nseir, MD

University Hospital of Lille

Information Provided By

University Hospital, Lille

Verification Date

September 2006

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

To Top