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: 18.1Level: LLTClassification code 10051190Term: Pneumonia Pseudomonas aeruginosaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-001706-34-PT
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 188
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 Main Objective: 1. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa<br>2. To evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilated patients;Secondary Objective: 1. To evaluate the serum pharmacokinetics (PK) of MEDI3902<br>2. To evaluate the serum anti-drug antibody (ADA) responses to MEDI3902<br>3. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa by mechanical ventilation status;Primary end point(s): - Incidence of nosocomial pneumonia caused by P aeruginosa <br><br>- Treatment emergent adverse events (TEAEs) treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs) through 49 days postdose;Timepoint(s) of evaluation of this end point: Through 49 days postdose<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. MEDI3902 serum concentration and PK parameters <br>2. MEDI3902 ADA response in serum <br>3. Incidence of nosocomial pneumonia caused by P aeruginosa while on mechanical ventilation<br>4. Incidence of nosocomial pneumonia caused by P aeruginosa after mechanical ventilation is no longer required;Timepoint(s) of evaluation of this end point: Through 49 days postdose<br>