ventilator-associated tracheobronchitis initiative to conduct antibiotic evaluation

Conditions: Ventilator Associated Tracheobronchitis; Tracheobronchitis

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 for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.

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 observational studies recommend antibiotic treatment for vat, some guidelines do not. the vatican is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for vat. the primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course.

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 \ 12000/ml or \ 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

Keywords: antibiotics ventilator associated tracheobronchitis mechanical ventilation critically ill