VATICAN: Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Other: Clinical observation without antibiotic therapy for VAT
Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.
|
Active Comparator: 7 day antibiotic course for VAT Patients will receive standard care and 7 day course of antibiotic therapy for VAT. |
Other: 7 day antibiotic course for VAT
Patients will receive standard care plus 7 day course of antibiotic.
|
Outcome Measures
Primary Outcome Measures
- Ventilator free days [28 days after randomization]
Days alive and free from mechanical ventilation
Secondary Outcome Measures
- 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).
Other Outcome Measures
- Nosocomial infections [28 days after randomization]
Incidence of culture positive nosocomial infections in 28 days
- Adverse events [28 days after randomization]
Severe adverse events
Eligibility Criteria
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:
-
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
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital OTOClinica | Fortaleza | CE | Brazil | |
2 | Hospital Vila Velha | Vila Velha | ES | Brazil | |
3 | Hospital Santa Casa de Belo Horizonte | Belo Horizonte | MG | Brazil | |
4 | Hospital Vila da Serra | Nova Lima | MG | Brazil | |
5 | Santa Casa de Misericórdia de Passos | Passos | MG | Brazil | |
6 | Hospital São Joao Del Rei | São João Del Rei | MG | Brazil | |
7 | Hospital Tricentenário | Olinda | PE | Brazil | |
8 | Hospital Universitário Regional do Norte do Paraná | Londrina | PR | Brazil | |
9 | Hospital Municipal de Maringá | Maringá | PR | Brazil | |
10 | Hospital Ernesto Dornelles | Porto Alegre | RS | Brazil | |
11 | Hospital Itapetininga | Itapetininga | SP | Brazil | |
12 | Hospital Unimed Limeira | Limeira | SP | Brazil | |
13 | Hospital Estadual Mario Covas | Santo André | SP | Brazil | |
14 | Hospital Santa Casa de Sorocaba | Sorocaba | SP | Brazil | |
15 | Hospital Samaritano | São Paulo | SP | Brazil | |
16 | Hospital São Paulo | São Paulo | SP | Brazil |
Sponsors and Collaborators
- 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 (BRICNet)
Investigators
- Principal Investigator: Bruno M Tomazini, MD, Hospital Sírio-Libanês
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 48749421.0.1001.5461