Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation

NCT05266066 | Recruiting DMC

• 1 other identifier: 48749421.0.1001.5461
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 16

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.

Conditions

Ventilator Associated Tracheobronchitis; Tracheobronchitis

Keywords

Antibiotics; Ventilator associated Tracheobronchitis; Mechanical ventilation; Critically ill

Outcome Measures

Primary Outcomes (1)

• Ventilator free days

  Days alive and free from mechanical ventilation

  28 days after randomization

Secondary Outcomes (8)

• Ventilator associated pneumonia-free survival (Key secondary outcome)

  28 days after randomization

• Mortality

  28 days after randomization

• Ventilator associated pneumonia

  14 and 28 days after randomization

• Intensive care unit free days

  28 days after randomization

• Organ dysfunction

  Between randomization and day 7.

Other Outcomes (2)

• Nosocomial infections

  28 days after randomization

• Adverse events

  28 days after randomization

Study Arms (2)

Clinical observation without antibiotic therapy for VAT

EXPERIMENTAL

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

7 day antibiotic course for VAT

ACTIVE COMPARATOR

Patients will receive standard care and 7 day course of antibiotic therapy for VAT.

Other: 7 day antibiotic course for VAT

Interventions

Clinical observation without antibiotic therapy for VAT OTHER

Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.

Clinical observation without antibiotic therapy for VAT

7 day antibiotic course for VAT OTHER

Patients will receive standard care plus 7 day course of antibiotic.

7 day antibiotic course for VAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• Hospital Israelita Albert Einstein: collaborator
• Hospital do Coracao: collaborator
• Hospital Moinhos de Vento: collaborator
• Hospital Alemão Oswaldo Cruz: collaborator
• BP - A Beneficência Portuguesa de São Paulo: collaborator
• Brazilian Research in Intensive Care Network (BRICNet): collaborator

Study Sites (16)

Hospital OTOClinica

Fortaleza, Ceará, Brazil

RECRUITING

Hospital Vila Velha

Vila Velha, Espírito Santo, Brazil

RECRUITING

Hospital Santa Casa de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

Hospital Vila da Serra

Nova Lima, Minas Gerais, Brazil

RECRUITING

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

RECRUITING

Hospital São Joao Del Rei

São João del Rei, Minas Gerais, Brazil

RECRUITING

Hospital Universitário Regional do Norte do Paraná

Londrina, Paraná, Brazil

RECRUITING

Hospital Municipal de Maringá

Maringá, Paraná, Brazil

RECRUITING

Hospital Tricentenário

Olinda, Pernambuco, Brazil

RECRUITING

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Hospital Itapetininga

Itapetininga, São Paulo, Brazil

RECRUITING

Hospital Unimed Limeira

Limeira, São Paulo, Brazil

RECRUITING

Hospital Estadual Mario Covas

Santo André, São Paulo, Brazil

RECRUITING

Hospital Samaritano

São Paulo, São Paulo, Brazil

RECRUITING

Hospital São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

Hospital Santa Casa de Sorocaba

Sorocaba, São Paulo, Brazil

RECRUITING

Related Publications (2)

• IMPACTO-MR, VATICAN Trial Investigators and BRICNet; Tomazini BM, Besen BAMP, Dietrich C, Gandara APR, Silva DP, Pinheiro CCG, Luz MN, Mattos RR, Reis LFL, Roepke RML, Duarte CSLG, Nassar Junior AP, Veiga VC, Arns B, Nascimento GM, Pereira AJ, Cavalcanti AB, Machado FR, Azevedo LCP. VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation): protocol for a multicenter randomized open-label trial of watchful waiting versus antimicrobial therapy for ventilator-associated tracheobronchitis. Crit Care Sci. 2024 Aug 26;36:e20240029en. doi: 10.62675/2965-2774.20240029-en. eCollection 2024.

  PMID: 39194024 BACKGROUND

• Tomazini BM, Nassar AP Jr, Lisboa TC, Azevedo LCP, Veiga VC, Catarino DGM, Fogazzi DV, Arns B, Piastrelli FT, Dietrich C, Negrelli KL, Jesuino IA, Reis LFL, Mattos RR, Pinheiro CCG, Luz MN, Spadoni CCDS, Moro EE, Bueno FR, Sampaio CSJC, Silva DP, Baldassare FP, Silva ACA, Veiga T, Barbante L, Lambauer M, Campos VB, Santos E, Santos RHN, Laranjeiras LN, Valeis N, Santucci E, Miranda TA, Patrocinio ACLD, Carvalho A, Sousa EMC, Sousa AHF, Malheiro DT, Bezerra IL, Rodrigues MB, Malicia JC, Silva SSD, Gimenes BDP, Sesin GP, Zavascki AP, Sganzerla D, Medeiros GS, Santos RDRMD, Silva FKR, Cheno MY, Abrahao CF, Oliveira Junior HA, Rocha LL, Nunes Neto PA, Pereira VC, Paciencia LEM, Bueno ES, Caser EB, Ribeiro LZ, Fernandes CCF, Garcia JM, Silva VFF, Santos AJD, Machado FR, Souza MA, Ferronato BR, Urbano HCA, Moreira DCA, Souza-Dantas VC, Duarte DM, Coelho J, Figueiredo RC, Foreque F, Romano TG, Cubos D, Spirale VM, Nogueira RS, Maia IS, Zandonai CL, Lovato WJ, Cerantola RB, Toledo TGP, Tomba PO, Almeida JR, Sanches LC, Pierini L, Cunha M, Sousa MT, Azevedo B, Dal-Pizzol F, Damasio DC, Bainy MP, Beduhn DAV, Jatoba JDVN, Moura MTF, Rego LRM, Silva AVD, Oliveira LP, Sodre Filho ES, Santos SSD, Neves IL, Leao VCA, Paes JLL, Silva MCM, Oliveira CD, Santiago RCB, Paranhos JLDR, Wiermann IGDS, Pedroso DFF, Sawada PY, Prestes RM, Nascimento GC, Grion CMC, Carrilho CMDM, Dantas RLAM, Silva EP, Silva ACD, Oliveira SMB, Golin NA, Tregnago R, Lima VP, Silva KGND, Boschi E, Buffon V, Machado AS, Capeletti L, Foernges RB, Carvalho AS, Oliveira Junior LC, Oliveira DC, Silva EM, Ribeiro J, Pereira FC, Salgado FB, Deutschendorf C, Silva CFD, Gobatto ALN, Oliveira CB, Dracoulakis MDA, Alvaia NOS, Souza RM, Araujo LLC, Melo RMV, Passos LCS, Vidal CFL, Rodrigues FLA, Kurtz P, Shinotsuka CR, Tavares MB, Santana IDV, Gavinho LMDS, Nascimento AB, Pereira AJ, Cavalcanti AB. IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):418-425. doi: 10.5935/0103-507X.20220209-pt. Epub 2023 Mar 3.

  PMID: 36888821 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Watchful Waiting; Anti-Infective Agents

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bruno M Tomazini, MD

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno M Tomazini, MD

CONTACT

5511982839173; bruno.mtomazini@hsl.org.br

Bruno AMP Besen, MD

CONTACT

brunobesen@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to Clinical observation without antibiotic therapy for VAT vs. 7 day antibiotic course.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 4, 2022
• Study Start: July 11, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after study completion.
• Access Criteria: Individual patient data might be shared upon request and approval by the study committee after the study completion.

Locations

BR (16)