Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation

NCT ID: NCT05266066

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 590 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2026-12-01

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.

Conditions

Ventilator Associated Tracheobronchitis; Tracheobronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Clinical observation without antibiotic therapy for VAT

Intervention Type: OTHER

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

7 day antibiotic course for VAT

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

Group Type: ACTIVE_COMPARATOR

7 day antibiotic course for VAT

Intervention Type: OTHER

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

Interventions

Clinical observation without antibiotic therapy for VAT

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

Intervention Type: OTHER

7 day antibiotic course for VAT

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: collaborator

Hospital Moinhos de Vento

OTHER

Sponsor Role: collaborator

Hospital Alemão Oswaldo Cruz

OTHER

Sponsor Role: collaborator

BP - A Beneficência Portuguesa de São Paulo

UNKNOWN

Sponsor Role: collaborator

Brazilian Research in Intensive Care Network (BRICNet)

UNKNOWN

Sponsor Role: collaborator

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno M Tomazini, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sírio-Libanês

Locations

Hospital São Joao Del Rei

São João del Rei, Minas Gerais, Brazil

Site Status: RECRUITING

Hospital OTOClinica

Fortaleza, Ceará, Brazil

Site Status: RECRUITING

Hospital Vila Velha

Vila Velha, Espírito Santo, Brazil

Site Status: RECRUITING

Hospital Santa Casa de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Site Status: RECRUITING

Hospital Vila da Serra

Nova Lima, Minas Gerais, Brazil

Site Status: RECRUITING

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

Site Status: RECRUITING

Hospital Universitário Regional do Norte do Paraná

Londrina, Paraná, Brazil

Site Status: RECRUITING

Hospital Municipal de Maringá

Maringá, Paraná, Brazil

Site Status: RECRUITING

Hospital Tricentenário

Olinda, Pernambuco, Brazil

Site Status: RECRUITING

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Hospital Itapetininga

Itapetininga, São Paulo, Brazil

Site Status: RECRUITING

Hospital Unimed Limeira

Limeira, São Paulo, Brazil

Site Status: RECRUITING

Hospital Estadual Mario Covas

Santo André, São Paulo, Brazil

Site Status: RECRUITING

Hospital Samaritano

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Hospital Santa Casa de Sorocaba

Sorocaba, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Bruno M Tomazini, MD

Role: CONTACT

bruno.mtomazini@hsl.org.br

5511982839173

Bruno AMP Besen, MD

Role: CONTACT

brunobesen@yahoo.com.br

Facility Contacts

Fabio H Lacerda, MD

Role: primary

Gedealvares Souza, MD

Role: primary

Claudio Dornas de Oliveira, MD

Role: primary

Hugo Urbano

Role: primary

Vanildes Bernardes

Role: primary

Jorge Paranhos, MD

Role: primary

Cintia Grion

Role: primary

Francielle Pereira, MD

Role: primary

Carlos Duarte, MD

Role: primary

Carla Rynkowski, MD

Role: primary

Vivian Irineu, MD

Role: primary

Luis Paciencia, MD

Role: primary

Caio Dernandes, MD

Role: primary

Livia Melro, MD

Role: primary

Flávia R Machado, MD

Role: primary

Vivian Leoneza, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 39194024 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36888821 (View on PubMed)

Other Identifiers

48749421.0.1001.5461

Identifier Type: -

Identifier Source: org_study_id