| Autor: |
Martins Tomazini, Bruno, Maccagnan Pinheiro Besen, Bruno Adler, Dietrich, Camila, Rossi Gandara, Ana Paula, Patrícia Silva, Debora, Gomes Pinheiro, Carla Cristina, Nascimento Luz, Mariane, Rodrigues de Mattos, Renata, Lima Reis, Luiz Fernando, Longo Roepke, Roberta Muriel, Luna Gomes Duarte, Carlos Sérgio, Nassar Júnior, Antônio Paulo, Cordeiro Veiga, Viviane, Arns, Beatriz, Marssola Nascimento, Giovanna, José Pereira, Adriano, Biasi Cavalcanti, Alexandre, Ribeiro Machado, Flávia, Pontes Azevedo, Luciano Cesar |
| Předmět: |
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| Zdroj: |
Critical Care Science; 2024, Vol. 36, p1-9, 9p |
| Abstrakt: |
Background: Ventilator-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. Methods: VATICAN 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. Conclusion: The 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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