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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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05266066). StuddyBuddy aggregates publicly available trial information.