Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
- Conditions
- Ventilator Associated TracheobronchitisTracheobronchitis
- Interventions
- Other: Clinical observation without antibiotic therapy for VATOther: 7 day antibiotic course for VAT
- Registration Number
- NCT05266066
- Lead Sponsor
- Hospital Sirio-Libanes
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 590
-
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:
- Temperature >38.0°C or <36°C OR leukocytes >12000/mL or <4000/mL or presence >10% of immature forms, AND
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical observation without antibiotic therapy for VAT Clinical observation without antibiotic therapy for VAT 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 7 day antibiotic course for VAT 7 day antibiotic course for VAT Patients will receive standard care and 7 day course of antibiotic therapy for VAT.
- Primary Outcome Measures
Name Time Method Ventilator free days 28 days after randomization Days alive and free from mechanical ventilation
- Secondary Outcome Measures
Name Time Method Mortality 28 days after randomization All cause mortality
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).
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.
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
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)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
Antibiotic free days 28 days after randomization Days alive and free from antibiotic
Trial Locations
- Locations (16)
Santa Casa de Misericórdia de Passos
🇧🇷Passos, MG, Brazil
Hospital Municipal de Maringá
🇧🇷Maringá, PR, Brazil
Hospital Itapetininga
🇧🇷Itapetininga, SP, Brazil
Hospital Unimed Limeira
🇧🇷Limeira, SP, Brazil
Hospital Santa Casa de Belo Horizonte
🇧🇷Belo Horizonte, MG, Brazil
Hospital Vila Velha
🇧🇷Vila Velha, ES, Brazil
Hospital Vila da Serra
🇧🇷Nova Lima, MG, Brazil
Hospital São Joao Del Rei
🇧🇷São João Del Rei, MG, Brazil
Hospital OTOClinica
🇧🇷Fortaleza, CE, Brazil
Hospital Universitário Regional do Norte do Paraná
🇧🇷Londrina, PR, Brazil
Hospital Tricentenário
🇧🇷Olinda, PE, Brazil
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, RS, Brazil
Hospital Santa Casa de Sorocaba
🇧🇷Sorocaba, SP, Brazil
Hospital Samaritano
🇧🇷São Paulo, SP, Brazil
Hospital Estadual Mario Covas
🇧🇷Santo André, SP, Brazil
Hospital São Paulo
🇧🇷São Paulo, SP, Brazil