EUCTR2016-000735-41-FRActive, not recruitingPhase 1
Antimicrobial treatment in patients with ventilator-associated tracheobronchitis: a prospective randomized placebo-controlled double-blind multicenter trial - TAVeM 2
CHRU LILLE0 sites315 target enrollmentStarted: November 15, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 315
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Antibiotic treatment in patients hospitalized with an acute exacerbation in chronic obstructive pulmonary disease. Effect of one day of antibiotic treatment compared t0 6 days of antibiotic treatment in patients who are clinically stable 24 hours after hospitalization. A prospective, randomized, double-blind trial - TaexaCOPAcute exacerbation of chronic ostructive pulmonary disease in hospitalized patients. All patients receive standard of care, and 1 day of intravenous antibiotics. In addition patients are randomized to treatment with Vibradox 200 mg QD in 5 days or matching placebo. The primary outcome variable is 6 minutes walking distance at day 14 after hospitalization.MedDRA version: 9.1Level: LLTClassification code 10056971Term: Infective exacerbation of chronic obstructive airways diseaseEUCTR2007-007275-16-DKDepartment of Infetious Diseases, Odense University Hospital
Active, not recruiting
Not Applicable
Antibiotic treatment for patients with infectious endocarditis: continuous infusion, guided by measurements of the antibiotic concentration in the blood, versus intermittent infusions (the CONTENT study).EUCTR2013-002807-32-DKAarhus University Hospital, Department of Cardiology40
Active, not recruiting
Phase 1
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Careventilator associated neumonia in intensive careEUCTR2021-002197-78-FRAssistance Publique - Hôpitaux de Paris590
Active, not recruiting
Phase 1
ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONSCommunity acquired pneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862EUCTR2019-001873-10-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS310
Terminated
Phase 4
Antimicrobial Treatment in Patients With Ventilator-associated TracheobronchitisMechanical Ventilation ComplicationCritical IllnessNCT03012360University Hospital, Lille103