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

Respiratory Tract Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122057
• Other study ID #: 2005/0506
• Status: Completed
• Phase: N/A
• First received: July 14, 2005
• Last updated: May 31, 2011
• Start date: June 2005
• Est. completion date: June 2007

Study information

• Verified date: September 2006
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cross Infection
• Nosocomial Infections
• Respiratory Tract Diseases

Intervention

Drug:
• antibiotic treatment

Locations

Country	Name	City	State
France	12 ICUs in north of France	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation
Secondary	length of intensive care unit (ICU) stay
Secondary	mortality rate
Secondary	ventilator-associated pneumonia rate