Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation

Launched by HOSPITAL SIRIO-LIBANES · Mar 2, 2022

Keywords

ClinConnect Summary

The VATICAN trial is a study looking at how effective antibiotics are for treating a condition called ventilator-associated tracheobronchitis (VAT) in patients who are on mechanical ventilation in the ICU. This trial compares two different approaches: giving some patients antibiotics for 7 days and simply observing other patients without antibiotics to see how they do. The goal is to find out if the antibiotic treatment is really necessary or if patients can be safely monitored without it.

To participate in this trial, patients need to be in an ICU and have been on a ventilator for at least 48 hours. They should have specific signs of VAT, like a fever or changes in their respiratory secretions. However, there are certain conditions that would exclude someone from joining, such as ongoing serious health issues or if they have already received antibiotics. If eligible and they choose to participate, patients will receive care as usual but will also be closely monitored during the study period. This research could help improve treatment options for patients with this condition in the future.

Gender

ALL

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 \<36°C OR leukocytes \>12000/mL or \<4000/mL or presence \>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 \<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