Evidence map›Paper›PMID 39194024›Full record

ArticleCritical care science2024

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.

IMPACTO-MR, VATICAN Trial Investigators and BRICNet, Bruno Martins Tomazini, Bruno Adler Maccagnan Pinheiro Besen, Camila Dietrich, Ana Paula Rossi Gandara, Debora Patrícia Silva, Carla Cristina Gomes Pinheiro, Mariane Nascimento Luz, Renata Rodrigues de Mattos, Luiz Fernando Lima Reis and 10 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Critical care science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05266066 (Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05266066 naactive not recruitingnot on this map

Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis

TypeinterventionalSponsorHospital Sirio-LibanesRan2022 to 2026Enrolled590ConditionsVentilator Associated Tracheobronchitis, TracheobronchitisArmsClinical observation without antibiotic therapy for VAT, 7 day antibiotic course for VAT
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

IMPACTO-MR, VATICAN Trial Investigators and BRICNet
Bruno Martins TomaziniHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-6763-6132
Bruno Adler Maccagnan Pinheiro BesenHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-3516-9696
Camila DietrichHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-5881-5286
Ana Paula Rossi GandaraHospital Sírio-Libanês - São Paulo (SP), Brazil.
Debora Patrícia SilvaHospital Sírio-Libanês - São Paulo (SP), Brazil.
Carla Cristina Gomes PinheiroHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-7613-6997
Mariane Nascimento LuzHospital Sírio-Libanês - São Paulo (SP), Brazil.
Renata Rodrigues de MattosHospital Sírio-Libanês - São Paulo (SP), Brazil.
Luiz Fernando Lima ReisHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-4040-2456
Roberta Muriel Longo RoepkeTrauma and Acute Care Surgery Intensive Care Unit, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-2214-5166
Carlos Sérgio Luna Gomes DuarteHospital Tricentenário - Olinda (PE), Brazil.
Antônio Paulo Nassar JúniorBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-0522-7445
Viviane Cordeiro VeigaBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-0287-3601
Beatriz ArnsHospital Moinhos de Vento - Porto Alegre (RS), Brazil.ORCID http://orcid.org/0000-0002-4464-9763
Giovanna Marssola NascimentoHospital Alemão Oswaldo Cruz - São Paulo (SP), Brazil.
Adriano José PereiraBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-3528-3800
Alexandre Biasi CavalcantiBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-2798-6263
Flávia Ribeiro MachadoBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-2356-4867
Luciano Cesar Pontes AzevedoBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-6759-3910

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVentilator-associated tracheobronchitis is a common condition among invasively ventilated patients in intensive care units, for which the best treatment strategy is currently unknown. We designed the VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation) trial to assess whether a watchful waiting antibiotic treatment strategy is noninferior to routine antibiotic treatment for ventilator-associated tracheobronchitis regarding days free of mechanical ventilation.

methodsVATICAN is a randomized, controlled, open-label, multicenter noninferiority trial. Patients with suspected ventilator-associated tracheobronchitis without evidence of ventilator-associated pneumonia or hemodynamic instability due to probable infection will be assigned to either a watchful waiting strategy, without antimicrobial administration for ventilator-associated tracheobronchitis and prescription of antimicrobials only in cases of ventilator-associated pneumonia, sepsis or septic shock, or another infectious diagnosis, or to a routine antimicrobial treatment strategy for seven days. The primary outcome will be mechanical ventilation-free days at 28 days, and a key secondary outcome will be ventilator-associated pneumonia-free survival. Through an intention-to-treat framework with a per-protocol sensitivity analysis, the primary outcome analysis will address noninferiority with a 20% margin, which translates to a 1.5 difference in ventilator-free days. Other analyses will follow a superiority analysis framework.

conclusionThe VATICAN trial will follow all national and international ethical standards. We aim to publish the trial in a high-visibility general journal and present it at critical care and infectious disease conferences for dissemination. These results will likely be immediately applicable to the bedside upon trial completion and will provide information with a low risk of bias for guideline development.

Indexed as

Anti-Bacterial AgentsBronchitisPneumonia, Ventilator-AssociatedRespiration, ArtificialTracheitisWatchful WaitingEquivalence Trials as TopicHumansIntensive Care UnitsMulticenter Studies as TopicRandomized Controlled Trials as TopicAnti-Bacterial Agents

Identifiers

PMID39194024
PMCPMC11321716

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.