EUCTR2015-001706-34-DE
Active, not recruiting
Phase 1
A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa. - EVADE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa
- Sponsor
- MedImmune, LLC
- Enrollment
- 429
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Colonized with Pseudomonas aeruginosa in respiratory tract, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
- •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 215
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 214
Exclusion Criteria
- •Pseudomonas disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving anti\-pseudomonas antibiotics; moribund patients.
Outcomes
Primary Outcomes
Not specified
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