Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation — VATICAN  

Tracheobronchitis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tracheobronchitis

• NCT number: NCT05266066
• Study type: Interventional
• Source: Hospital Sirio-Libanes
• Contact: Bruno M Tomazini, MD
• Phone: 5511982839173
• Email: bruno.mtomazini@hsl.org.br
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2022
• Completion date: December 1, 2026