Respiratory Tract Diseases Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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