Overview

Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Lille
Collaborator:
Ministry of Health, France
Treatments:
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Ceftriaxone
Ciprofloxacin
Imipenem
Linezolid
Criteria
Inclusion Criteria:

- All adult patients hospitalized in the ICU with a first episode of VAT diagnosed >48
hours after starting invasive mechanical ventilation are eligible for this study.

VAT is defined using the following criteria:

1. absence of new infiltrate on chest X ray

2. two of the three following conditions: fever > 38.5 °C or <36.5, leucocyte count >
than 12 000 cells per μL or
3. and positive tracheal aspirate (≥105 cfu/mL)

Exclusion Criteria:

- long-term tracheostomy at ICU admission

- patients who develop VAP before VAT

- patients already receiving antibiotics active against all the microorganisms
responsible for VAT

- severe immunosuppression

- pregnancy or breastfeeding

- patients <18 years

- patients already included in another study, with potential interaction with the
primary objective of the current study

- known resistance to imipenem and ciprofloxacin of bacteria responsible for VAT

- treatment limitation decisions

- moribund patients (likely to die within 24 h)

- allergy to any of study drugs: hypersensitivity to any carbapenem, severe
hypersensitivity (for example anaphylactic reaction or severe cutaneous reaction) to
any other antibiotic form beta-lactam group (such as penicillin or cephalosporin),
severe hypersensitivity (for example anaphylactic reaction) to any other antibiotic
from beta-lactam group (penicillin, monobactam or carbapenem), hypersensitivity to
quinolones