ventilator-associated pneumonitis MedDRA version: 19.0 Level: LLT Classification code 10047263 Term: Ventilation pneumonitis System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ceftriaxone panpharma
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 74578-69-1
Current Sponsor code: ME1
Other descriptive name: CEFTRIAXONE SODIUM
Concen
Sponsors
CHRU LILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All adult patients with a first episode of VAT diagnosed >48 hours after starting invasive mechanical ventilation are eligible for this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 315 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: long-term tracheostomy at ICU admission -modified Clinical Pulmonary Infection Score (CPIS) =6 at the day of randomization -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 -absence of social insurance -patients under guardianship -known resistance of bacteria responsible for VAT to imipenem and ciprofloxacin -treatment limitation decisions -moribund patients -allergy to any of study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the efficiency of two durations (3 or 7 days) of antibiotic treatment for ventilator-associated tracheobronchitis (VAT), compared with no antibiotic treatment, in reducing the incidence of transition from VAT to ventilator-associated pneumonia (VAP).;Secondary Objective: 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 ;Primary end point(s): The percentage of patients with a transition from VAT to VAP, from randomization to day 28, or until the end of invasive mechanical ventilation (if it happens before D28). VAP will be considered as subsequent to VAT, when it is diagnosed >24h after VAT occurrence. Only first episodes of VAP will be taken into account. ;Timepoint(s) of evaluation of this end point: From randomization to day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -duration of mechanical ventilation-free days from randomization to day 28, or until ICU discharge (if it happens first) -duration of antibiotic free-days from randomization to day 28, or until ICU discharge (if it happens first) -length of ICU stay -mortality at day 28 and day 90 -percentage of patients with ICU-acquired colonization related to MDR bacteria, from randomization to day 28, or until ICU discharge (if it happens before D28) -percentage of patients with ICU-acquired infection related to MDR bacteria, from randomization to day 28, or until ICU discharge (if it happens before D28) -percentage of patients with ventilator-associated events, from randomization to day 28, or until ICU discharge (if it happens before D28) ;Timepoint(s) of evaluation of this end point: 90 days after randomization | — |
Countries
France
Contacts
Public ContactFédération Recherche Clinique
CHRU LILLE
Outcome results
None listed