Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

  • STATUS
    Recruiting
  • days left to enroll
    41
  • participants needed
    154
  • sponsor
    University Hospital, Lille
Updated on 24 January 2021
pneumonia
antibiotics
imipenem
invasive mechanical ventilation
tracheobronchitis

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).

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.

Details
Condition Critical Illness, Mechanical Ventilation Complication, critically ill
Treatment linezolid, Placebo, Ciprofloxacin, ceftriaxone, Imipenem
Clinical Study IdentifierNCT03012360
SponsorUniversity Hospital, Lille
Last Modified on24 January 2021

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