Informations générales (source: ClinicalTrials.gov)
Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial (TAVeM2)
Interventional
Phase 4
University Hospital, Lille (Voir sur ClinicalTrials)
février 2018
septembre 2023
03 août 2024
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHRU - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 <than 4000 cells per μL purulent tracheal secretions
3. and positive tracheal aspirate (≥105 cfu/mL)
- 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 <than 4000 cells per μL purulent tracheal secretions
3. and positive tracheal aspirate (≥105 cfu/mL)
- 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