EUCTR2016-000735-41-FR
Active, not recruiting
Phase 1
Antimicrobial treatment in patients with ventilator-associated tracheobronchitis: a prospective randomized placebo-controlled double-blind multicenter trial - TAVeM 2
CHRU LILLE0 sites315 target enrollmentNovember 15, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ventilator-associated pneumonitis
- Sponsor
- CHRU LILLE
- Enrollment
- 315
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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