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Clinical Trials/EUCTR2016-000735-41-FR
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.

Registry
who.int
Start Date
November 15, 2016
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHRU LILLE

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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