Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis — TAVeM2  

Critical Illness Clinical Trial

Official title: Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial

Status Recruiting

Clinical Trial Summary

Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).

Clinical Trial Description

The main objective of this randomized controlled multicenter double-blind trial is to assess the efficiency of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, in reducing the incidence of transition from VAT to ventilator-associated pneumonia (VAP).

Secondary objectives are to determine the impact of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, on:

• duration of mechanical-ventilation free days

• duration of antibiotic free days

• length of ICU stay

• mortality at day 28 and day 90

• incidence of ICU-acquired colonization related to multidrug resistant (MDR) bacteria

• incidence of ICU-acquired infection related to MDR bacteria

• incidence of ventilator-associated events After informed consent, patients will be randomized (1:1:1) to receive 0 (control group), 3 or 7 days (experimental groups) of antibiotic treatment for VAT

Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:

• patients with early-onset VAT with no risk factor for MDR bacteria will receive ceftriaxone (2 g iv every 24h).

• patients with late-onset VAT (after day 4 of mechanical ventilation), or with at least one risk factor for MDR bacteria will receive imipenem (1 g iv every 8h), and ciprofloxacin (400 mg iv every 8h) as empirical treatment. When methicillin-resistant Staphylococcus aureus is suspected, linezolid (600 mg iv every 12h) will be added to empirical treatment.

Patients randomized in control group will receive 7 days of placebo, and those randomized in the first experimental arm (3 days of antibiotics) will receive 4 days of placebo. ;

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Complication

• NCT number: NCT03012360
• Study type: Interventional
• Source: University Hospital, Lille
• Contact: Saad NSEIR, MD,PhD
• Phone: 3 20 44 40 84
• Email: saadalla.nseir@chru-lille.fr
• Status: Recruiting
• Phase: Phase 4
• Start date: February 8, 2018
• Completion date: September 2023