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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Clinical observation without antibiotic therapy for VAT
Other interventionPatients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.
7 day antibiotic course for VAT
Other interventionPatients will receive standard care plus 7 day course of antibiotic.
Treatment groups
590 Participants
are divided into 2 treatment groupsGroup A: Clinical observation without antibiotic therapy for VATExperimental treatment 1 intervention
Group B: 7 day antibiotic course for VATActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ventilator free days
Days alive and free from mechanical ventilation
Time frame
28 days after randomizationSecondary outcomes
1
Ventilator associated pneumonia-free survival (Key secondary outcome)
The time between randomization and the diagnostic event of ventilator associated pneumonia or death
Time frame
28 days after randomization2
Mortality
All cause mortality
Time frame
28 days after randomization3
Ventilator associated pneumonia
Ventilator associated pneumonia incidence
Time frame
14 and 28 days after randomization4
Intensive care unit free days
Days alive and free from intensive care unit
Time frame
28 days after randomizationOther outcomes
1
Nosocomial infections
Incidence of culture positive nosocomial infections in 28 days
Time frame
28 days after randomization2
Adverse events
Severe adverse events
Time frame
28 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
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