Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT05266066
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05266066
Study Brief:
Protocol Section:
NCT05266066