Overview
The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.
Description
There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observational studies recommend antibiotic treatment for VAT, some guidelines do not. The VATICAN is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. Patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for VAT. The primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course.
Eligibility
Inclusion Criteria:
- Admission to one of the participating ICUs
- Invasive Mechanical ventilation ≥ 48 hours
- Available chest imaging of screening day
- Clinical diagnosis of VAT, defined by the presence of:
- Temperature >38.0°C or <36°C OR leukocytes >12000/mL or <4000/mL or presence >10% of immature forms, AND
- Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration
- Culture of tracheal secretion from the day of screening under analysis or collected
for analysis
Exclusion Criteria:
- Pregnant or lactating women
- Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening
- Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose > 0.1mcg/kg/min of noradrenaline or equivalent in the past 6 hours
- Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days
- Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more
- Presence of pulmonary radiological image suggestive of new infectious infiltrate
- Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult
- Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization
- Neutropenic patients (neutrophils <1000/mL)
- Known severe immunosuppression
- Tracheostomized patients at the time of screening
- Inclusion in the study in the past 30 days
- Expected limitation of care or early withdrawal of supportive therapies (< 7 days)
- Patients with a survival expectancy of less than 48 hours
- Refusal of consent to participate in the study