Status:
RECRUITING
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Lead Sponsor:
Hospital Sirio-Libanes
Collaborating Sponsors:
Hospital Israelita Albert Einstein
Hospital do Coracao
Conditions:
Ventilator Associated Tracheobronchitis
Tracheobronchitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observatio...
Eligibility Criteria
Inclusion
- 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:
- Temperature \>38.0°C or \<36°C OR leukocytes \>12000/mL or \<4000/mL or presence \>10% of immature forms, AND
- 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
- 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 \<1000/mL)
- Known severe immunosuppression
- Tracheostomized patients at the time of screening
- Inclusion in the study in the past 30 days
- Expected limitation of care or early withdrawal of supportive therapies (\< 7 days)
- Patients with a survival expectancy of less than 48 hours
- Refusal of consent to participate in the study
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT05266066
Start Date
July 11 2022
End Date
December 1 2026
Last Update
June 19 2025
Active Locations (16)
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1
Hospital OTOClinica
Fortaleza, Ceará, Brazil
2
Hospital Vila Velha
Vila Velha, Espírito Santo, Brazil
3
Hospital Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
4
Hospital Vila da Serra
Nova Lima, Minas Gerais, Brazil