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.

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.

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:

  1. Temperature >38.0°C or <36°C OR leukocytes >12000/mL or <4000/mL or presence >10% of immature forms, AND
  2. 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

Individual patient data (IPD) might be shared upon request and approval by the study committee after the study completion.

One year after study completion.

Individual patient data might be shared upon request and approval by the study committee after the study completion.