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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
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Chastre, Jean (Service de Médecine Intensive Réanimation. Institut de Cardiologie. Groupe Hospitalier Pitié-Salpêtrière. Assistance Publique-Hôpitaux de Paris. Sorbonne University) ;
François, Bruno (Réanimation Polyvalente and Inserm CIC 1435 & UMR 1092. CHU) ;
Bourgeois, Marc (AZ Sint-Jan Brugge-Oostende AV) ;
Komnos, Apostolos (General Hospital of Larissa) ;
Ferrer, Ricard (Hospital Universitari Vall d'Hebron) ;
Rahav, Galia (Chaim Sheba Medical Center. Sackler School of Medicine. Tel Aviv University) ;
De Schryver, Nicolas (Clinique Saint-Pierre) ;
Lepape, Alain (Hospices Civils de Lyon Hôpital Lyon Sud) ;
Koksal, Iftihar (Faculty of Medicine. Trabzon and Acibadem University Faculty of Medicine. Karadeniz Technical University) ;
Luyt, Charles-Edouard (Service de Médecine Intensive Réanimation. Institut de Cardiologie. Groupe Hospitalier Pitié-Salpêtrière. Assistance Publique-Hôpitaux de Paris. Sorbonne University) ;
Sánchez-García, Miguel (Hospital Clínico San Carlos. Unidad de Cuidados Intensivos) ;
Torres, Antoni (Hospital Clínic i Provincial de Barcelona. Servei de Pneumologia) ;
Eggimann, Philippe (Department of Locomotor Apparatus. Centre Hospitalier Universitaire Vaudois CHUV) ;
Koulenti, Despoina (2nd Critical Care Department. Attikon University Hospital. National and Kapodistrian. University of Athens) ;
Holland, Thomas L. (Duke Clinical Research Institute) ;
Ali, Omar (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Shoemaker, Kathryn (Respiratory and Immunology. BioPharmaceuticals R&D. AstraZeneca) ;
Ren, Pin (Respiratory and Immunology. BioPharmaceuticals R&D. AstraZeneca) ;
Sauser, Julien (Infection Control Program. Faculty of Medicine. Geneva University Hospitals) ;
Ruzin, Alexey (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Tabor, David E. (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Akhgar, Ahmad (Clinical Pharmacology and Quantitative Pharmacology. Clinical Pharmacology and Safety Sciences. BioPharmaceuticals R&D. AstraZeneca) ;
Wu, Yuling (Clinical Pharmacology and Quantitative Pharmacology. Clinical Pharmacology and Safety Sciences. BioPharmaceuticals R&D. AstraZeneca) ;
Jiang, Yu (Clinical Pharmacology and Quantitative Pharmacology. Clinical Pharmacology and Safety Sciences. BioPharmaceuticals R&D. AstraZeneca) ;
DiGiandomenico, Antonio (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Colbert, Susan (Oncology. US SM&M. AstraZeneca) ;
Vandamme, Drieke (Inserm CIC 1435. CHU) ;
Coenjaerts, Frank (University Medical Center Utrecht) ;
Malhotra-Kumar, Surbhi (University of Antwerp. Laboratory of Medical Microbiology) ;
Timbermont, Leen (University of Antwerp. Laboratory of Medical Microbiology) ;
Oliver, Antonio (Hospital Universitari Son Espases (Palma de Mallorca, Balears)) ;
Barraud, Olivier (INSERM U1092. Centre Hospitalier Universitaire de Limoges. Université Limoges) ;
Bellamy, Terramika (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Bonten, Marc (Julius Center for Health Science and Primary Care. University Medical Center Utrecht. Utrecht University) ;
Goossens, Herman (Laboratory of Medical Microbiology. Vaccine and Infectious Disease Institute. University of Antwerp) ;
Reisner, Colin (DevPro Biopharma) ;
Esser, Mark T. (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Jafri, Hasan S. (Late-Stage Development. Respiratory and Immunology. BioPharmaceuticals R&D. AstraZeneca) ;
Joannidis, Michael ;
Klimscha, Walter ;
De Waele, Elisabeth ;
Devriendt, Jacques ;
Huberlant, Vincent ;
Depuydt, Pieter ;
Van Boxstael, Sam ;
Peric, Mladen ;
Kopic, Jasminka ;
Hanauer, Michal ;
Hruby, Tomas ;
Sramek, Vladimir ;
Svoboda, Petr ;
Vymazal, Tomas ;
Novacek, Martin ;
Annane, Djillali ;
Mira, Jean-Paul ;
Souweine, Bertrand ;
Dequin, Pierre-François ;
Meziani, Ferhat ;
Stephan, François ;
Nseir, Saad ;
Gibot, Sebastien ;
Schwebel, Carole ;
Plantefeve, Gaetan ;
Diehl, Jean-Luc ;
Richard, Christian ;
Lamer, Christian ;
Klouche, Kada ;
Jaber, Samir ;
Zakynthinos, Epaminondas ;
Filntisis, Georgios ;
Zakynthinos, Spyros ;
Koutsoukou, Antonia ;
Saroglou, Georgios ;
Nikolaou, Charikleia ;
Vlachogianni, Glykeria ;
Pnevmatikos, Ioannis ;
Mandragos, Konstantinos ;
Kremer, Ildiko ;
Rozgonyi, Zsolt Dezso ;
Marjanek, Zsuzsa ;
Martin-Loeches, Ignacio ;
Singer, Pierre ;
Van Heerden, Vernon ;
Carmeli, Yehuda ;
Povoa, Pedro ;
AlvarezSeoane, Antonio ;
Moura, Pedro ;
Gonzalez, Filipe ;
Ramirez, Paula ;
Torres Marti, Antonio ;
Ferrer Roca, Ricard ;
Oteiza, Lorena ;
Escudero, Dolores ;
Piacentini, Enrique ;
Vera-Artazcoz, Paula (Institut d'Investigació Biomèdica Sant Pau) ;
Tamayo, Luis ;
Gonzalez Gallego, Miguel Angel ;
Suberviola Canas, Borja ;
Figueira, Iglesias ;
Leon, Rafael ;
Korten, Volkan ;
Akova, Murat ;
Wyncoll, Duncan ;
Whitehouse, Tony ;
Hopkins, Phil ;
Sim, Malcolm ;
Golan, Yoav ;
Zervos, Marcus ;
Vazquez, Jose ;
Cherabuddi, Kartikeya ;
Smulian, George ;
Rouphael, Nadine ;
Welker, James ;
Sims, Mathew ;
Van Duin, David ;
McCarthy, Todd ;
Polk, Christopher
Background: Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. [...]
2022 -  10.1186/s13054-022-04204-9
Critical Care, Vol. 26 Núm. 1 (december 2022) , p. 355
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13 p, 786.1 KB |
A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients
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Rello, Jordi (Hospital Universitari Vall d'Hebron) ;
Krenn, Claus-Georg (Medical University of Vienna) ;
Locker, Gottfried (Medical University of Vienna) ;
Pilger, Ernst (University Hospital Graz, Graz, Austria) ;
Madl, Christian (Medical University of Vienna) ;
Balica, Laura (Emergency Clinical Hospital Bucharest) ;
Dugernier, Thierry (Clinique St. Pierre, Ottignies, Belgium) ;
Laterre, Pierre-Francois (St. Luc University Hospital UCL, Université Catholique de Louvain, Brussels, Belgium) ;
Spapen, Herbert (University Hospital Vrije Universiteit Brussels, Brussels, Belgium) ;
Depuydt, Pieter (UZ Gent, Gent, Belgium) ;
Vincent, Jean-Louis (Université Libre de Bruxelles) ;
Bogár, Lajos (University of Pécs, Pécs, Hungary) ;
Szabó, Zsuzsanna (Uzsoki Hospital, Budapest, Hungary) ;
Völgyes, Barbara (Bajcsy Zsilinszky Hospital and Polyclinic, Budapest, Hungary) ;
Máñez, Rafael (Hospital Universitari de Bellvitge) ;
Çakar, Nahit (Istanbul University Capa Medical Faculty, Istanbul, Turkey) ;
Ramazanoglu, Atilla (Akdeniz University, Antalya, Turkey) ;
Topeli, Arzu (Hacettepe University Hospital, Ankara, Turkey) ;
Mastruzzo, Maria A. (Hospital Dr. Carlos Bocalandro, Buenos Aires, Argentina) ;
Jasovich, Abel (Sanatorio Güemes, Buenos Aires, Argentina) ;
Remolif, Christian G. (Hospital "Heroes de Malvinas", Buenos Aires, Argentina) ;
del Carmen Soria, Liliana (Hospital Central Mendoza, Ciudad de Mendoza, Argentina) ;
Andresen Hernandez, Max A. (Pontificia Universidad Católica de Chile) ;
Ruiz Balart, Carolina (Hospital Dr. Sótero del Rio, Santiago, Chile) ;
Krémer, Ildikó (Flor Ferenc County Hospital, Kistarcsa, Hungary) ;
Molnár, Zsolt (University of Szeged, Szeged, Hungary) ;
von Sonnenburg, Frank (University of Munich, Germany) ;
Lyons, Arthur (Walter Reed Army Institute of Research) ;
Joannidis, Michael (Medical University of Innsbruck, Innsbruck, Austria) ;
Burgmann, Heinz (Medical University of Vienna) ;
Welte, Tobias (Hannover Medical School, Hannover, Germany) ;
Klingler, Anton (Assign Data Management and Biostatistics GmbH, Innsbruck, Austria) ;
Hochreiter, Romana (Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna, Austria) ;
Westritschnig, Kerstin (Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna, Austria) ;
Universitat Autònoma de Barcelona
Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. [...]
2017 - 10.1186/s13054-017-1601-9
Critical Care, Vol. 21 (february 2017)
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