← Back to all trials
Active Not Recruiting
NCT05266066
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Conditions: Ventilator Associated Tracheobronchitis, Tracheobronchitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 590
Sponsor: Hospital Sirio-Libanes
Location: Hospital OTOClinica Fortaleza Ceará
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.
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:
1. Temperature \>38.0°C or \12000/mL or \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 \
Source: ClinicalTrials.gov (NCT05266066). StuddyBuddy aggregates publicly available trial information.