Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
NCT ID: NCT02696902
Last Updated: 2021-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2016-03-25
2019-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MEDI3902 500 mg
Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
MEDI3902
Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
MEDI3902 1500 mg
Participants will receive a single IV dose of 1500 mg MEDI3902.
MEDI3902
Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
Interventions
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MEDI3902
Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Innovative Medicines Initiative
OTHER
Antibacterial Resistance Leadership Group
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Englewood, Colorado, United States
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Gainesville, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Cincinnati, Ohio, United States
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Innsbruck, , Austria
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Vienna, , Austria
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Bruges, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Haine-Saint-Paul, , Belgium
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Ottignies, , Belgium
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Slavonski Brod, , Croatia
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Brno, , Czechia
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Děčín, , Czechia
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Kolín, , Czechia
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Kyjov, , Czechia
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Teplice, , Czechia
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Argenteuil, , France
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Clermont-Ferrand, , France
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Garches, , France
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La Tronche, , France
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Le Kremlin-Bicêtre, , France
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Le Plessis-Robinson, , France
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Lille, , France
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Limoges, , France
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Montpellier, , France
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Nancy, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pierre-Bénite, , France
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Strasbourg, , France
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Tours, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Kistarcsa, , Hungary
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Vác, , Hungary
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Dublin, , Ireland
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Almada, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Viana do Castelo, , Portugal
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Getafe, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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San Sebastián de los Reyes, , Spain
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Santander, , Spain
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Tarragona, , Spain
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Terrassa, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
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Edgbaston, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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References
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Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Redacted CSP for CT.gov results
D5470C00004 Redacted SAP for CT.gov results
Other Identifiers
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D5470C00004
Identifier Type: -
Identifier Source: org_study_id
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