Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation (VATICAN)

Hospital Sirio-Libanes

Status: Enrolling

Conditions: Ventilator Associated Tracheobronchitis; Tracheobronchitis

Treatments: Other: Clinical observation without antibiotic therapy for VAT; Other: 7 day antibiotic course for VAT

Study type: Interventional

Funder types: Other

Identifiers

NCT05266066

48749421.0.1001.5461

Details and patient eligibility

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.

Full 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 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.

Enrollment: 590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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590 participants in 2 patient groups

Clinical observation without antibiotic therapy for VAT

Experimental group

Description:

Patients will receive standard care and no antibiotic therapy for VAT. Antibiotics will be prescribed if other infections and/or organ dysfunction ensues (especially shock) or there is progression to pneumonia

Treatment:

Other: Clinical observation without antibiotic therapy for VAT

7 day antibiotic course for VAT

Active Comparator group

Description:

Patients will receive standard care and 7 day course of antibiotic therapy for VAT.

Treatment:

Other: 7 day antibiotic course for VAT