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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Completed
• CT.gov ID: NCT00122057
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	12 ICUs in north of France	Lille		France

Sponsors and Collaborators

• University Hospital, Lille

Investigators

• Principal Investigator: Saad Nseir, MD, University Hospital of Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00122057
• Other Study ID Numbers: 2005/0506
• First Posted: Jul 21, 2005
• Last Update Posted: Jun 1, 2011
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: ventilator-associated tracheobronchitis; nosocomial tracheobronchitis
• Additional relevant MeSH terms: Cross Infection; Respiratory Tract Diseases; Anti-Bacterial Agents

Study Results

No Results Posted as of Jun 1, 2011