Actively Recruiting
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Led by Hospital Sirio-Libanes · Updated on 2025-06-19
590
Participants Needed
16
Research Sites
229 weeks
Total Duration
On this page
Sponsors
H
Hospital Sirio-Libanes
Lead Sponsor
H
Hospital Israelita Albert Einstein
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission to one of the participating ICUs
- Invasive mechanical ventilation for 48 hours or more
- Chest imaging available on the screening day
- Clinical diagnosis of ventilator-associated tracheobronchitis defined by:
- Temperature above 38.0°C or below 36°C, or white blood cell count above 12000/mL or below 4000/mL or more than 10% immature forms, AND
- Onset or change in purulent tracheal secretions or increased need for aspiration
- Culture of tracheal secretion collected on the day of screening or available for analysis
You will not qualify if you...
- Pregnant or lactating women
- Current indication for or use of systemic antibiotics at screening
- Hemodynamic instability unresponsive to treatment or increased vasopressor dose over 0.1 mcg/kg/min in past 6 hours
- Worsening gas exchange with increased oxygen fraction by 20% or positive end-expiratory pressure by 3 cm H2O after at least 2 days of stability
- Mechanical ventilation for 21 days or longer
- New pulmonary infection signs on chest imaging
- Previous lung disease complicating pneumonia diagnosis
- Previous diagnosis of ventilator-associated pneumonia during this hospitalization
- Neutropenia with neutrophils below 1000/mL
- Severe immunosuppression
- Tracheostomy present at screening
- Participation in this study within the last 30 days
- Expected care limitation or withdrawal of support within 7 days
- Survival expectancy less than 48 hours
- Refusal to consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hospital OTOClinica
Fortaleza, Ceará, Brazil
Actively Recruiting
2
Hospital Vila Velha
Vila Velha, Espírito Santo, Brazil
Actively Recruiting
3
Hospital Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Actively Recruiting
4
Hospital Vila da Serra
Nova Lima, Minas Gerais, Brazil
Actively Recruiting
5
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
Actively Recruiting
6
Hospital São Joao Del Rei
São João del Rei, Minas Gerais, Brazil
Actively Recruiting
7
Hospital Universitário Regional do Norte do Paraná
Londrina, Paraná, Brazil
Actively Recruiting
8
Hospital Municipal de Maringá
Maringá, Paraná, Brazil
Actively Recruiting
9
Hospital Tricentenário
Olinda, Pernambuco, Brazil
Actively Recruiting
10
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
11
Hospital Itapetininga
Itapetininga, São Paulo, Brazil
Actively Recruiting
12
Hospital Unimed Limeira
Limeira, São Paulo, Brazil
Actively Recruiting
13
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
Actively Recruiting
14
Hospital Samaritano
São Paulo, São Paulo, Brazil
Actively Recruiting
15
Hospital São Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
16
Hospital Santa Casa de Sorocaba
Sorocaba, São Paulo, Brazil
Actively Recruiting
Research Team
B
Bruno M Tomazini, MD
CONTACT
B
Bruno AMP Besen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here