Clinical trial NCT05266066: Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Official title: Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Associated Tracheobronchitis
Tracheobronchitis
Keywords: Antibiotics
Ventilator associated Tracheobronchitis
Mechanical ventilation
Critically ill
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: Hospital Israelita Albert Einstein
name: Hospital do Coracao
name: Hospital Moinhos de Vento
name: Hospital Alemão Oswaldo Cruz
name: BP - A Beneficência Portuguesa de São Paulo
name: Brazilian Research in Intensive Care Network (BRICNet)
First posted: 2022-03-04
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to Clinical observation without antibiotic therapy for VAT vs. 7 day antibiotic course.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ventilator free days
timeFrame: 28 days after randomization
Secondary outcomes:
measure: Ventilator associated pneumonia-free survival (Key secondary outcome)
timeFrame: 28 days after randomization
measure: Mortality
timeFrame: 28 days after randomization
measure: Ventilator associated pneumonia
timeFrame: 14 and 28 days after randomization
measure: Intensive care unit free days
timeFrame: 28 days after randomization
measure: Organ dysfunction
timeFrame: Between randomization and day 7.
measure: Microbiological isolation of multi-resistant bacteria
timeFrame: 28 days after randomization
measure: Antibiotic free days
timeFrame: 28 days after randomization
measure: Cost analysis
timeFrame: For the first 28 days after randomization
Other outcomes:
measure: Nosocomial infections
timeFrame: 28 days after randomization
measure: Adverse events
timeFrame: 28 days after randomization
Locations:
city: Fortaleza
country: Brazil
facility: Hospital OTOClinica
state: CE
city: Vila Velha
country: Brazil
facility: Hospital Vila Velha
state: ES
city: Belo Horizonte
country: Brazil
facility: Hospital Santa Casa de Belo Horizonte
state: MG
city: Nova Lima
country: Brazil
facility: Hospital Vila da Serra
state: MG
city: Passos
country: Brazil
facility: Santa Casa de Misericórdia de Passos
state: MG
city: São João Del Rei
country: Brazil
facility: Hospital São Joao Del Rei
state: MG
city: Olinda
country: Brazil
facility: Hospital Tricentenário
state: PE
city: Londrina
country: Brazil
facility: Hospital Universitário Regional do Norte do Paraná
state: PR
city: Maringá
country: Brazil
facility: Hospital Municipal de Maringá
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: RS
city: Itapetininga
country: Brazil
facility: Hospital Itapetininga
state: SP
city: Limeira
country: Brazil
facility: Hospital Unimed Limeira
state: SP
city: Santo André
country: Brazil
facility: Hospital Estadual Mario Covas
state: SP
city: Sorocaba
country: Brazil
facility: Hospital Santa Casa de Sorocaba
state: SP
city: São Paulo
country: Brazil
facility: Hospital Samaritano
state: SP
city: São Paulo
country: Brazil
facility: Hospital São Paulo
state: SP
Study officials:
affiliation: Hospital Sírio-Libanês
name: Bruno M Tomazini, MD
role: PRINCIPAL_INVESTIGATOR
References: