Clinical trial looking at the safety and efficacy of MEDI3902 in the prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital
Phase 1
- Conditions
- Prevention of nosocomial pneumonia caused by Pseudomonas aeruginosaMedDRA version: 18.1 Level: LLT Classification code 10051190 Term: Pneumonia Pseudomonas aeruginosa System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-001706-34-ES
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 429
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method