Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
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Purpose
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 | Intervention |
|---|---|
|
Respiratory Tract Diseases Nosocomial Infections |
Drug: antibiotic treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- duration of mechanical ventilation
- length of intensive care unit (ICU) stay
- mortality rate
- ventilator-associated pneumonia rate
| Enrollment: | 58 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
More Information
No publications provided by University Hospital, Lille
Additional 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 |
| Study First Received: | July 14, 2005 |
| Last Updated: | May 31, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Lille:
|
ventilator-associated tracheobronchitis nosocomial tracheobronchitis |
Additional relevant MeSH terms:
|
Respiratory Tract Diseases Cross Infection Infection Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013