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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
590
Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.
Patients will receive standard care plus 7 day course of antibiotic.
Hospital OTOClinica
Fortaleza, Ceará, Brazil
RECRUITINGHospital Vila Velha
Vila Velha, Espírito Santo, Brazil
Ventilator free days
Days alive and free from mechanical ventilation
Time frame: 28 days after randomization
Ventilator associated pneumonia-free survival (Key secondary outcome)
The time between randomization and the diagnostic event of ventilator associated pneumonia or death
Time frame: 28 days after randomization
Mortality
All cause mortality
Time frame: 28 days after randomization
Ventilator associated pneumonia
Ventilator associated pneumonia incidence
Time frame: 14 and 28 days after randomization
Intensive care unit free days
Days alive and free from intensive care unit
Time frame: 28 days after randomization
Organ dysfunction
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.
Time frame: Between randomization and day 7.
Microbiological isolation of multi-resistant bacteria
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)
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Hospital Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
RECRUITINGHospital Vila da Serra
Nova Lima, Minas Gerais, Brazil
RECRUITINGSanta Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
RECRUITINGHospital São Joao Del Rei
São João del Rei, Minas Gerais, Brazil
RECRUITINGHospital Universitário Regional do Norte do Paraná
Londrina, Paraná, Brazil
RECRUITINGHospital Municipal de Maringá
Maringá, Paraná, Brazil
RECRUITINGHospital Tricentenário
Olinda, Pernambuco, Brazil
RECRUITINGHospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITING...and 6 more locations
Time frame: 28 days after randomization
Antibiotic free days
Days alive and free from antibiotic
Time frame: 28 days after randomization
Cost analysis
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).
Time frame: For the first 28 days after randomization