Tracheobronchitis, Ventilator Associated Tracheobronchitis
Conditions
Keywords
Antibiotics, Ventilator associated Tracheobronchitis, Mechanical ventilation, Critically ill
Brief 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.
Detailed 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.
Interventions
OTHERClinical observation without antibiotic therapy for VAT
Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.
OTHER7 day antibiotic course for VAT
Patients will receive standard care plus 7 day course of antibiotic.
Sponsors
Hospital Sirio-Libanes
Hospital Israelita Albert Einstein
Hospital do Coracao
Hospital Moinhos de Vento
Hospital Alemão Oswaldo Cruz
BP - A Beneficência Portuguesa de São Paulo
Brazilian Research In Intensive Care Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients will be randomized 1:1 to Clinical observation without antibiotic therapy for VAT vs. 7 day antibiotic course.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free days | 28 days after randomization | Days alive and free from mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator associated pneumonia-free survival (Key secondary outcome) | 28 days after randomization | The time between randomization and the diagnostic event of ventilator associated pneumonia or death |
| Mortality | 28 days after randomization | All cause mortality |
| Ventilator associated pneumonia | 14 and 28 days after randomization | Ventilator associated pneumonia incidence |
| Intensive care unit free days | 28 days after randomization | Days alive and free from intensive care unit |
| Organ dysfunction | Between randomization and day 7. | Variation in organ dysfunction (measured by the Sequential Organ Failure Assessment Score). Sequential Organ Failure Assessment scores are measured in 6 organ systems (cardiovascular, hematologic, gastrointestinal, renal, pulmonary and neurologic), with each organ scored from 0 to 4, resulting in an aggregated score that ranges from 0 to 24, with higher scores indicating greater dysfunction. |
| Microbiological isolation of multi-resistant bacteria | 28 days after randomization | Microbiological isolation of multi-resistant bacteria. Any isolation of by microbiological cultures of multi-resistant bacteria following the definition: Acinetobacter baumannii: Resistant to carbapenems and/or polymyxins Pseudomonas aeruginosa: Resistant to carbapenems and/or polymyxins Enterobacteriaceae: Resistant to carbapenems and/or polymyxins (in enterobacteria naturally sensitive to polymyxins) Vancomycin-resistant Enterococcus faecium (VRE) Methicillin/Oxacillin Resistant Staphylococcus aureus (MRSA) Methicillin/Oxacillin-Resistant Coagulase Negative Staphylococcus (MRSA) |
| Antibiotic free days | 28 days after randomization | Days alive and free from antibiotic |
| Cost analysis | For the first 28 days after randomization | Cost effectiveness analysis. Direct and indirect hospital costs will be measured and used in the analyses. For that, a local costing system will be built, using the absorption costing methodology (top-down). |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORBruno M Tomazini, MD
Hospital Sirio-Libanes
Outcome results
None listed