Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Sirio-Libanes
About this trial
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
Qualifiers
Admission to one of the participating ICUs
Invasive Mechanical ventilation ≥ 48 hours
Available chest imaging of screening day
Temperature >38.0°C or <36°C OR leukocytes >12000/mL or <4000/mL or presence >10% of immature forms, AND
Disqualifiers
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
Trial design
Treatments tested in this trial
- Clinical observation without antibiotic therapy for VAT
- 7 day antibiotic course for VAT
Treatment groups
590 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital Sirio-Libanes
Lead sponsor
Hospital Israelita Albert Einstein
Collaborator
Hospital do Coracao
Collaborator
Hospital Moinhos de Vento
Collaborator
Hospital Alemão Oswaldo Cruz
Collaborator
BP - A Beneficência Portuguesa de São Paulo
Collaborator
Brazilian Research In Intensive Care Network
Collaborator
Source ClinicalTrials.gov