Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator Associated Tracheobronchitis
- Sponsor
- Hospital Sirio-Libanes
- Enrollment
- 590
- Locations
- 16
- Primary Endpoint
- Ventilator free days
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Ventilator free days
Time Frame: 28 days after randomization
Days alive and free from mechanical ventilation
Secondary Outcomes
- Cost analysis(For the first 28 days after randomization)
- Ventilator associated pneumonia-free survival (Key secondary outcome)(28 days after randomization)
- Mortality(28 days after randomization)
- Organ dysfunction(Between randomization and day 7.)
- Microbiological isolation of multi-resistant bacteria(28 days after randomization)
- Ventilator associated pneumonia(14 and 28 days after randomization)
- Intensive care unit free days(28 days after randomization)
- Antibiotic free days(28 days after randomization)