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: 20.0 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-CZ
- 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 143
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 143
Exclusion Criteria
Pseudomonas disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified 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 <br> Secondary Objective: 1. To evaluate the serum pharmacokinetics (PK) of MEDI3902<br> 2. To evaluate the serum anti-drug antibody (ADA) responses to<br> MEDI3902<br> ;<br> Timepoint(s) of evaluation of this end point: Through 49 days postdose<br> ;<br> Main 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<br> ;<br> Primary end point(s): - Incidence of nosocomial pneumonia caused by P aeruginosa <br> - Treatment emergent adverse events (TEAEs) treatment emergent<br> serious adverse events (TESAEs), adverse events of special interest<br> (AESIs) through 49 days postdose<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1. MEDI3902 serum concentration and PK parameters<br> 2. MEDI3902 ADA response in serum<br> ;<br> Timepoint(s) of evaluation of this end point: Through 49 days postdose<br>