Antimicrobial treatment in patients with ventilator-associated tracheobronchitis: a prospective randomized placebo-controlled double-blind multicenter trial

Phase 1

• Conditions: ventilator-associated pneumonitis; MedDRA version: 19.0Level: LLTClassification code 10047263Term: Ventilation pneumonitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000735-41-FR
• Lead Sponsor: CHRU LILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 315

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified