Evaluating antibiotic treatment for ventilator-associated tracheobronchitis

Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis

This study tests if a 7-day course of antibiotics helps ICU patients with ventilator-associated tracheobronchitis more than just watching their condition without treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 590 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Sirio-Libanes (Academic / other)
• Locations: 16 sites (Fortaleza, Ceará and 15 other locations)
• Trial ID: NCT05266066 on ClinicalTrials.gov

What this trial studies

The VATICAN trial is a national, multicenter, non-inferiority trial that investigates the effectiveness of a 7-day antibiotic treatment compared to clinical observation in ICU patients diagnosed with ventilator-associated tracheobronchitis. The study aims to address the lack of consensus and high-quality data regarding the necessity of antibiotics for this condition. Patients will be randomized to receive either antibiotics or no antibiotics, with the primary hypothesis being that clinical observation is non-inferior to antibiotic treatment. This trial seeks to provide clearer guidelines for managing ventilator-associated tracheobronchitis in critically ill patients.

Who should consider this trial

Good fit: Ideal candidates are ICU patients on invasive mechanical ventilation for at least 48 hours with a clinical diagnosis of ventilator-associated tracheobronchitis.

Not a fit: Patients who are pregnant, lactating, or those requiring immediate antibiotic treatment for other conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective management strategies for ventilator-associated tracheobronchitis, potentially reducing unnecessary antibiotic use.

How similar studies have performed: While some observational studies suggest antibiotic treatment may be beneficial, this trial is among the first to rigorously evaluate this approach through a randomized controlled design.

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

Where this trial is running

Fortaleza, Ceará and 15 other locations

• Hospital OTOClinica — Fortaleza, Ceará, Brazil (Recruiting)
• Hospital Vila Velha — Vila Velha, Espírito Santo, Brazil (Recruiting)
• Hospital Santa Casa de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
• Hospital Vila da Serra — Nova Lima, Minas Gerais, Brazil (Recruiting)
• Santa Casa de Misericórdia de Passos — Passos, Minas Gerais, Brazil (Recruiting)
• Hospital São Joao Del Rei — São João del Rei, Minas Gerais, Brazil (Recruiting)
• Hospital Universitário Regional do Norte do Paraná — Londrina, Paraná, Brazil (Recruiting)
• Hospital Municipal de Maringá — Maringá, Paraná, Brazil (Recruiting)
• Hospital Tricentenário — Olinda, Pernambuco, Brazil (Recruiting)
• Hospital Ernesto Dornelles — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
• Hospital Itapetininga — Itapetininga, São Paulo, Brazil (Recruiting)
• Hospital Unimed Limeira — Limeira, São Paulo, Brazil (Recruiting)
• Hospital Estadual Mario Covas — Santo André, São Paulo, Brazil (Recruiting)
• Hospital Samaritano — São Paulo, São Paulo, Brazil (Recruiting)
• Hospital São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
• Hospital Santa Casa de Sorocaba — Sorocaba, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Bruno M Tomazini, MD — Hospital Sirio-Libanes
• Study coordinator: Bruno M Tomazini, MD

Conditions Ventilator Associated Tracheobronchitis; Tracheobronchitis; Antibiotics; Ventilator associated Tracheobronchitis; Mechanical ventilation; Critically ill