NCT05266066

Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Clinical observation without antibiotic therapy for VAT	Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.
OTHER	7 day antibiotic course for VAT	Patients will receive standard care plus 7 day course of antibiotic.

Timeline

• Start date: 2022-07-11
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2022-03-04
• Last updated: 2025-06-19

Locations

16 sites across 1 country: Brazil