Study identifier:D5470C00004
ClinicalTrials.gov identifier:NCT02696902
EudraCT identifier:N/A
CTIS identifier:N/A
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
Pseudomonas aeruginosa
Phase 2
No
MEDI3902
All
188
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Nov 2020 by MedImmune, LLC
MedImmune, LLC
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET, Antibacterial Resistance Leadership Group (ARLG), National Institute of Allergy and Infectious Disease (NIAID)
Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
Location
Location
Limoges, France, 87042
Location
Barcelona, Spain, 08036
Location
Madrid, Spain, 28040
Location
Oviedo, Spain, 33011
Location
Tours, France, 37000
Location
Clermont-ferrand, France, 63003
Location
Getafe, Spain, 28905
Location
Nancy, France, 54035
Arms | Assigned Interventions |
---|---|
Experimental: MEDI3902 500 mg Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902. | Drug: MEDI3902 Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902. |
Placebo Comparator: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902. | Other: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902. |
Experimental: MEDI3902 1500 mg Participants will receive a single IV dose of 1500 mg MEDI3902. | Drug: MEDI3902 Participants will receive a single IV dose of 500 mg or 1500 mg MEDI3902. |
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