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14 p, 1.9 MB |
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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11 p, 838.8 KB |
Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia : a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study)
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Welte, Tobias (Carl-Neuberg-Str. 1, 30625 Hannover, Germany) ;
Dellinger, R. Phillip (Cooper Medical School of Rowan University. Department of Medicine) ;
Ebelt, Henning (Universitätsklinikum Halle (Saale). Klinik und Poliklinik für Innere Medizin III) ;
Ferrer, Miguel (Institut d'Investigacions Biomèdiques August Pi i Sunyer) ;
Opal, Steven M. (Rhode Island Hospital. Infectious Disease Division) ;
Singer, Mervyn (University College London. Bloomsbury Institute of Intensive Care Medicine) ;
Vincent, Jean-Louis (Erasme University Hospital. Department of Intensive Care) ;
Werdan, Karl (St. James's Hospital. Trinity Centre for Health Sciences) ;
Martin-Loeches, Ignacio (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT)) ;
Almirall i Pujol, Jordi (Hospital de Mataró. Consorci Sanitari del Maresme) ;
Artigas Raventós, Antoni (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT)) ;
Ignacio Ayestarán, Jose (Hospital Universitari Son Espases (Palma de Mallorca, Balears)) ;
Nuding, Sebastian (Hospital Universitari MútuaTerrassa (Terrassa, Catalunya)) ;
Ferrer, Ricard (Hospital Universitari Vall d'Hebron. Institut de Recerca) ;
Sirgo Rodríguez, Gonzalo (Hospital Universitari Joan XXIII de Tarragona) ;
Shankar-Hari, Manu (Guy's and St. Thomas' NHS Foundation Trust. Intensive Care Medicine) ;
Álvarez Lerma, Francisco (Hospital del Mar (Barcelona, Catalunya)) ;
Riessen, Reimer (Universitätsklinikum Tübingen. Internistische Intensivstation) ;
Sirvent, Josep-Maria (Hospital Universitari de Girona Doctor Josep Trueta) ;
Kluge, Stefan (Universitätsklinikum Hamburg-Eppendorf. Klinik für Intensivmedizin) ;
Zacharowski, Kai (Universitätsklinikum Frankfurt. Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie) ;
Bonastre Mora, Juan (Hospital Universitari i Politècnic La Fe (València)) ;
Lapp, Harald (Medizinische Klinik, Kardiologie und Intensivmedizin, Helios Klinikum Erfurt, Erfurt, Germany) ;
Wöbker, Gabriele (Klinik für Intensivmedizin, Helios Universitätsklinikum Wuppertal, Wuppertal, Germany) ;
Achtzehn, Ute (Klinikum Chemnitz gGmbH. Innere Medizin IV - Pneumologie) ;
Brealey, David (Critical Care Unit, NIHR University College London Hospitals Biomedical Research Centre, University College London Hospitals, NHS Foundation Trust, London, UK) ;
Kempa, Axel (Katharinenhospital, Stuttgart. Klinik für Allgemeine Innere Medizin) ;
Sánchez García, Miguel (Hospital Clínico San Carlos (Madrid)) ;
Brederlau, Jörg (Helios Klinikum Berlin-Buch, Klinik für Intensivmedizin) ;
Kochanek, Matthias (University Hospital of Cologne. Department I of Internal Medicine) ;
Reschreiter, Henrik Peer (Poole Hospital NHS Foundation Trust) ;
Wise, Matthew P. (Heath Park, Cardiff) ;
Belohradsky, Bernd H. (University Children's Hospital Munich) ;
Bobenhausen, Iris (Biotest AG) ;
Dälken, Benjamin (Biotest AG) ;
Dubovy, Patrick (Biotest AG) ;
Langohr, Patrick (Biotest AG) ;
Mayer, Monika (Biotest AG) ;
Schüttrumpf, Jörg (Biotest AG) ;
Wartenberg-Demand, Andrea (Biotest AG) ;
Wippermann, Ulrike (Biotest AG) ;
Wolf, Daniele (Biotest AG) ;
Torres, Antoni (Hospital Clínic i Provincial de Barcelona)
The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). [...]
2018 - 10.1007/s00134-018-5143-7
Intensive Care Medicine, Vol. 44 (april 2018) , p. 438-448
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8 p, 202.9 KB |
Prevention of Ventilator-Associated Pneumonia : The Multimodal Approach of the Spanish ICU "Pneumonia Zero" Program*
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Álvarez Lerma, Francisco (Institut Hospital del Mar d'Investigacions Mèdiques) ;
Palomar Martínez, Mercedes (Institut Hospital del Mar d'Investigacions Mèdiques) ;
Sánchez-García, Miguel (Hospital Clínico San Carlos (Madrid)) ;
Martínez-Alonso, Montserrat ;
Álvarez-Rodríguez, Joaquín (Service of Intensive Care Medicine, SEMICYUC Working Group on Safety, Quality and Management, Hospital de Fuenlabrada, Fuenlabrada, Madrid, Spain) ;
Lorente, Leonardo (Hospital Universitario de Canarias (La Laguna)) ;
Arias-Rivera, Susana (Hospital Universitario de Getafe (Madrid)) ;
Garcia, Rosa (Hospital de Basurto (Bilbao, Biscaia)) ;
Gordo, Federico (Hospital Universitario del Henares ( Madrid)) ;
Añón, José Manuel (Instituto de Investigación Sanitaria del Hospital Universitario La Paz) ;
Jam-Gatell, Rosa (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT)) ;
Vázquez-Calatayud, Mónica (Clínica Universidad de Navarra) ;
Agra Varela, Yolanda (Patient Safety Unit, Spanish Ministry of Health, Social Policy and Equality, Madrid, Spain) ;
Universitat Autònoma de Barcelona
Supplemental Digital Content is available in the text. The "Pneumonia Zero" project is a nationwide multimodal intervention based on the simultaneous implementation of a comprehensive evidence-based bundle measures to prevent ventilator-associated pneumonia in critically ill patients admitted to the ICU. [...]
2018 - 10.1097/CCM.0000000000002736
Critical Care Medicine, Vol. 46 (january 2018) , p. 181-188
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