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Sponsored by: |
University Hospital, Lille |
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Information provided by: | University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT00122057 |
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 |
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Respiratory Tract Diseases Nosocomial Infections |
Drug: antibiotic treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 390 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2008 |
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 ( = 0.025, = 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Saad Nseir, MD | (33) 320444495 | s-nseir@chru-lille.fr |
France | |
12 ICUs in north of France | Recruiting |
lille, France | |
Contact: Saad Nseir, MD |
Principal Investigator: | Saad Nseir, MD | University Hospital of Lille |
Study ID Numbers: | 2005/0506 |
Study First Received: | July 14, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00122057 History of Changes |
Health Authority: | France: Ministry of Health |
ventilator-associated tracheobronchitis nosocomial tracheobronchitis |
Anti-Infective Agents Anti-Bacterial Agents Respiratory Tract Diseases Cross Infection |
Anti-Infective Agents Anti-Bacterial Agents Respiratory Tract Diseases Therapeutic Uses |
Infection Pharmacologic Actions Cross Infection |