7 research outputs found
Prevalence and management of delirium in intensive care units in the Netherlands:An observational multicentre study
- Author
- Berger Elke
- Bethlehem Carina
- de Man-van Ginkel Janneke M.
- de Vreede Els W.
- Hofstra Lieuwe S.
- Hoiting Oscar
- Holman Susanne
- Hoogendoorn Emma E.
- Koets Jeroen
- Koopmans Matty
- Mijzen Lisa
- Nooteboom Fleur
- Raben Adrienne M. T. J.
- Riekerk Bea
- Rinket Martin A.
- Schoonderbeek F. Jeannette
- Simons Koen S.
- Slooter Arjen J. C.
- Streefkerk Jorn O.
- ten Cate Julia
- Toscano Eryk
- van den Boogaard Mark
- van den Oever Huub L. A.
- van der Woude Meta
- van Santen Susanne
- Verkade Martijn
- Vermeulen Hester
- Vos Piet
- Wils Evert-Jan
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/12/2020
- Field of study
Objectives: This study aimed to determine the prevalence, risk factors of delirium and current practice of delirium management in intensive care units of various levels of care.Research methodology/design: Prospective multicentre cohort study.Setting: In all adult patients admitted to one of the participating intensive care units on World Delirium Awareness Day 2018, delirium point and period prevalence rates were measured between ICU admission and seven days after the index day.Results: In total, 28 (33%) Dutch intensive care units participated in this study. Point-prevalence was 23% (range 41), and period-prevalence was 42% (range 70). University intensive care units had a significantly higher delirium point-prevalence compared with non-university units (26% vs.15%, p = 0.02). No signif-icant difference were found in period prevalence (50% vs. 39%, p = 0.09). Precipitating risk factors, infection and mechanical ventilation differed significantly between delirium and non-delirium patients. No differences were observed for predisposing risk factors. A delirium protocol was present in 89% of the ICUs. Mean delirium assessment compliance measured was 84% (+/- 19) in 14 units and estimated 59% (+/- 29) in the other 14.Conclusion: Delirium prevalence in Dutch intensive care units is substantial and occurs with a large variation, with the highest prevalence in university units. Precipitating risk factors were more frequent in patients with delirium. In the majority of units a delirium management protocol is in place. (C) 2020 Elsevier Ltd. All rights reserved.</p
Notice of Retraction and Replacement: Oostdijk et al. Effects of Decontamination of the Oropharynx and Intestinal Tract on Antibiotic Resistance in ICUs: A Randomized Clinical Trial. JAMA. 2014;312(14):1429-1437.
- Author
- Bergmans Dennis
- Bernards Alexandra T.
- Bindels Alexander
- Bonten Marc J. M.
- Bosch Frank H.
- Brandenburg Afke
- Brimicombe Roland
- de Jong Remko
- de Jonge Evert
- de Smet Anne Marie G. A.
- Demmendaal Kees
- Fijen Jan Willem
- Gruteke Paul
- Hart Helga
- Jansz Arjan
- Kesecioglu Jozef
- Koeman Mirelle
- Mascini Ellen
- Oostdijk Evelien A. N.
- Oudbier Joke
- Peerbooms Paul
- Purmer Ilse
- Raben Adrienne
- Rijkeboer Annemieke
- Rothbarth Philip
- Schultz Marcus J.
- Thijsen Steven
- van der Vorm Eric
- van der Zwet Wil C.
- van Elsacker-Niele Anne-MarieW.
- van Essen Einar H. R.
- van Griethuysen Arjanne
- van Steveninck Fred A. L.
- van Tiel Frank
- Visser Caroline E.
- Winsser Lex J.
- Publication venue
- 'American Medical Association (AMA)'
- Publication date
- 01/01/2017
- Field of study
Effects of Decontamination of the Oropharynx and Intestinal Tract on Antibiotic Resistance in ICUs A Randomized Clinical Trial
- Author
- Bergmans Dennis
- Bernards Alexandra T.
- Bindels Alexander
- Bonten Marc J. M.
- Bosch Frank H.
- Brandenburg Afke
- Brimicombe Roland
- de Jong Remko
- de Jonge Evert
- de Smet Anne Marie G. A.
- Demmendaal Kees
- Fijen Jan Willem
- Gruteke Paul
- Hart-Sweet Helga
- Jansz Arjan
- Kesecioglu Jozef
- Koeman Mirelle
- Mascini Ellen
- Oostdijk Evelien A. N.
- Oudbier Joke
- Peerbooms Paul
- Purmer Ilse
- Raben Adrienne
- Rijkeboer Annemieke
- Rothbarth Philip
- Schultz Marcus J.
- Thijsen Steven
- Van der Vorm Eric
- Van der Zwet Wil C.
- van Elsacker-Niele Anne-Marie W.
- van Essen Einar H. R.
- van Griethuysen Arjanne
- van Steveninck Fred (A. ) L.
- van Tiel Frank
- Visser Caroline E.
- Winsser Lex J.
- Publication venue
- 'American Medical Association (AMA)'
- Publication date
- 08/10/2014
- Field of study
IMPORTANCE Selective decontamination of the digestive tract (SDD) and selective oropharyngeal decontamination (SOD) are prophylactic antibiotic regimens used in intensive care units (ICUs) and associated with improved patient outcome. Controversy exists regarding the relative effects of both measures on patient outcome and antibiotic resistance. OBJECTIVE To compare the effects of SDD and SOD, applied as unit-wide interventions, on antibiotic resistance and patient outcome. DESIGN, SETTING, AND PARTICIPANTS Pragmatic, cluster randomized crossover trial comparing 12 months of SOD with 12 months of SDD in 16 Dutch ICUs between August 1, 2009, and February 1, 2013. Patients with an expected length of ICU stay longer than 48 hours were eligible to receive the regimens, and 5881 and 6116 patients were included in the clinical outcome analysis for SOD and SDD, respectively. INTERVENTIONS Intensive care units were randomized to administer either SDD or SOD. MAIN OUTCOMES AND MEASURES Unit-wide prevalence of antibiotic-resistant gram-negative bacteria. Secondary outcomes were day-28 mortality, ICU-acquired bacteremia, and length of ICU stay. RESULTS In point-prevalence surveys, prevalences of antibiotic-resistant gram-negative bacteria in perianal swabs were significantly lower during SDD compared with SOD; for aminoglycoside resistance, average prevalence was 5.6%(95% CI, 4.6%-6.7%) during SDD and 11.8%(95% CI, 10.3%-13.2%) during SOD (P <.001). During both interventions the prevalence of rectal carriage of aminoglycoside-resistant gram-negative bacteria increased 7% per month (95% CI, 1%-13%) during SDD (P = .02) and 4% per month (95% CI, 0%-8%) during SOD (P = .046; P = .40 for difference). Day 28-mortality was 25.4% and 24.1% during SOD and SDD, respectively (adjusted odds ratio, 0.96 [95% CI, 0.88-1.06]; P = .42), and there were no statistically significant differences in other outcome parameters or between surgical and nonsurgical patients. Intensive care unit-acquired bacteremia occurred in 5.9% and 4.6% of the patients during SOD and SDD, respectively (odds ratio, 0.77 [95% CI, 0.65-0.91]; P = .002; number needed to treat, 77). CONCLUSIONS AND RELEVANCE Unit-wide application of SDD and SOD was associated with low levels of antibiotic resistance and no differences in day-28 mortality. Compared with SOD, SDD was associated with lower rectal carriage of antibiotic-resistant gram-negative bacteria and ICU-acquired bacteremia but a more pronounced gradual increase in aminoglycoside-resistant gram-negative bacteria
Effects of Decontamination of the Oropharynx and Intestinal Tract on Antibiotic Resistance in ICUs
- Author
- Adrienne Raben
- Afke Brandenburg
- Alexander Bindels
- Alexandra T. Bernards
- Anne Marie G.A. de Smet
- Anne-Marie W. van Elsacker-Niele
- Annemieke Rijkeboer
- Arjan Jansz
- Arjanne van Griethuysen
- Caroline E. Visser
- Dennis Bergmans
- Einar H. R. van Essen
- Ellen Mascini
- Eric van der Vorm
- Evelien A. N. Oostdijk
- Evert de Jonge
- Frank H. Bosch
- Frank van Tiel
- Fred (A.) L. van Steveninck
- Helga Hart-Sweet
- Ilse Purmer
- Jan Willem Fijen
- Joke Oudbier
- Jozef Kesecioglu
- Kees Demmendaal
- Lex J. Winsser
- Marc J. M. Bonten
- Marcus J. Schultz
- Mirelle Koeman
- Paul Gruteke
- Paul Peerbooms
- Philip Rothbarth
- Remko de Jong
- Roland Brimicombe
- Steven Thijsen
- Wil C. van der Zwet
- Publication venue
- 'American Medical Association (AMA)'
- Publication date
- Field of study
Erratum to: Guidelines for the use and interpretation of assays for monitoring autophagy (3rd edition) (Autophagy, 12, 1, 1-222, 10.1080/15548627.2015.1100356
- Author
- Abdelmohsen Kotb
- Abe Akihisa
- Abedin Md Joynal
- Abeliovich Hagai
- Adachi Hiroaki
- Adams Christopher M.
- Adams Peter D.
- Adeli Khosrow
- Adhihetty Peter J.
- Adler Sharon G.
- Agam Galila
- Agarwal Rajesh
- Aghi Manish K.
- Agnello Maria
- Agostinis Patrizia
- Aguilar Patricia V.
- Aguirre-Ghiso Julio
- Airoldi Edoardo M.
- Ait-Si-Ali Slimane
- Akematsu Takahiko
- Akporiaye Emmanuel T.
- Al-Rubeai Mohamed
- Albaiceta Guillermo M.
- Albanese Chris
- Albani Diego
- Albert Matthew L.
- Aldudo Jesus
- Algül Hana
- Alirezaei Mehrdad
- Alloza Iraide
- Almasan Alexandru
- Almonte-Beceril Maylin
- Alnemri Emad S.
- Alonso Covadonga
- Altan-Bonnet Nihal
- Altieri Dario C.
- Alvarez Silvia
- Alvarez-Erviti Lydia
- Alves Sandro
- Amadoro Giuseppina
- Amano Atsuo
- Amantini Consuelo
- Ambrosio Santiago
- Amelio Ivano
- Amer Amal O.
- Amessou Mohamed
- Amon Angelika
- An Zhenyi
- Anania Frank A.
- Andersen Stig U.
- Andley Usha P.
- Andreadi Catherine K.
- Andrieu-Abadie Nathalie
- Anel Alberto
- Ann David K.
- Anoopkumar-Dukie Shailendra
- Antonioli Manuela
- Aoki Hiroshi
- Apostolova Nadezda
- Aquila Saveria
- Aquilano Katia
- Araki Koichi
- Arama Eli
- Aranda Agustin
- Araya Jun
- Arcaro Alexandre
- Arias Esperanza
- Arimoto Hirokazu
- Ariosa Aileen R.
- Armstrong Jane L.
- Arnould Thierry
- Arozena Abraham Acevedo
- Arsov Ivica
- Asanuma Katsuhiko
- Askanas Valerie
- Asselin Eric
- Atarashi Ryuichiro
- Atherton Sally S.
- Atkin Julie D.
- Attardi Laura D.
- Auberger Patrick
- Auburger Georg
- Aurelian Laure
- Autelli Riccardo
- Avagliano Laura
- Avantaggiati Maria Laura
- Avrahami Limor
- Awale Suresh
- Azad Neelam
- Bachetti Tiziana
- Backer Jonathan M.
- Bae Dong-Hun
- Bae Jae-Sung
- Bae Ok-Nam
- Bae Soo Han
- Baehrecke Eric H.
- Baek Seung-Hoon
- Baghdiguian Stephen
- Bagniewska-Zadworna Agnieszka
- Bai Hua
- Bai Jie
- Bai Xue-Yuan
- Bailly Yannick
- Balaji Kithiganahalli Narayanaswamy
- Balduini Walter
- Ballabio Andrea
- Balzan Rena
- Banerjee Rajkumar
- Bao Haijun
- Barbato Daniele Lettieri
- Barbeau Benoit
- Barrachina Maria D.
- Barreiro Esther
- Bartel Bonnie
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- Bassham Diane C.
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- Beale Rupert
- Beaulieu Jean-François
- Beck George R.
- Becker Christoph
- Beckham J. David
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- Begley Thomas J.
- Behl Christian
- Behrends Christian
- Behrens Georg M. N.
- Behrns Kevin E.
- Bejarano Eloy
- Belaid Amine
- Belleudi Francesca
- Berchem Guy
- Bergamaschi Daniele
- Bergami Matteo
- Berkhout Ben
- Berliocchi Laura
- Bernard Amélie
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- Bernassola Francesca
- Bertolotti Anne
- Bess Amanda S.
- Besteiro Sébastien
- Bettuzzi Saverio
- Bhalla Savita
- Bhattacharyya Shalmoli
- Bhutia Sujit K.
- Biagosch Caroline
- Bianchi Michele Wolfe
- Biard-Piechaczyk Martine
- Billes Viktor
- Bincoletto Claudia
- Bingol Baris
- Bird Sara W.
- Bitoun Marc
- Bjedov Ivana
- Blackstone Craig
- Blanc Lionel
- Blanco Guillermo A.
- Blomhoff Heidi Kiil
- Boada-Romero Emilio
- Boes Marianne
- Boesze-Battaglia Kathleen
- Boise Lawrence H.
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- Boman Andrea
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- Bosch Jürgen
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- Boucher Marie-Josée
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- Cavallini Gabriella
- Ceccherini Isabella
- Cecconi Francesco
- Cederbaum Arthur I.
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- Cerella Claudia
- Cervia Davide
- Cetrullo Silvia
- Ceña Valentín
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- Cheong Heesun
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- Chesney Jason
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- Wang Mei
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- Weis Simone Nardin
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- Westermann Benedikt
- Weyand Cornelia M.
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- White Eileen
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- Wild Franziska
- Wildenberg Manon E.
- Wileman Tom
- Wilkinson Deepti Srinivas
- Wilkinson Simon
- Willbold Dieter
- Williams Chris
- Williams Katherine
- Williamson Peter R.
- Winklhofer Konstanze F.
- Witkin Steven S.
- Wohlgemuth Stephanie E.
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- Xie Zhonglin
- Xilouri Maria
- Xiong Yuyan
- Xu Chuanshan
- Xu Congfeng
- Xu Feng
- Xu Haoxing
- Xu Hongwei
- Xu Jian
- Xu Jianzhen
- Xu Jinxian
- Xu Liang
- Xu Xiaolei
- Xu Yangqing
- Xu Ye
- Xu Zhi-Xiang
- Xu Ziheng
- Xue Yu
- Yamada Takahiro
- Yamamoto Ai
- Yamanaka Koji
- Yamashina Shunhei
- Yamashiro Shigeko
- Yan Bing
- Yan Bo
- Yan Xianghua
- Yan Zhen
- Yanagi Yasuo
- Yang Dun-Sheng
- Yang Jin-Ming
- Yang Liu
- Yang Minghua
- Yang Pei-Ming
- Yang Peixin
- Yang Qian
- Yang Wannian
- Yang Wei Yuan
- Yang Xuesong
- Yang Yi
- Yang Ying
- Yang Zhifen
- Yang Zhihong
- Yao Meng-Chao
- Yao Pamela J.
- Yao Xiaofeng
- Yao Zhenyu
- Yao Zhiyuan
- Yasui Linda S.
- Ye Mingxiang
- Yedvobnick Barry
- Yeganeh Behzad
- Yeh Elizabeth S.
- Yeyati Patricia L.
- Yi Fan
- Yi Long
- Yin Xiao-Ming
- Yip Calvin K.
- Yoo Yeong-Min
- Yoo Young Hyun
- Yoon Seung-Yong
- Yoshida Ken-Ichi
- Yoshimori Tamotsu
- Young Ken H.
- Yu Huixin
- Yu Jane J.
- Yu Jin-Tai
- Yu Jun
- Yu Li
- Yu W. Haung
- Yu Xiao-Fang
- Yu Zhengping
- Yuan Junying
- Yuan Zhi-Min
- Yue Beatrice Y. J. T.
- Yue Jianbo
- Yue Zhenyu
- Zacks David N.
- Zacksenhaus Eldad
- Zaffaroni Nadia
- Zaglia Tania
- Zakeri Zahra
- Zecchini Vincent
- Zeng Jinsheng
- Zeng Min
- Zeng Qi
- Zervos Antonis S.
- Zhang Donna D.
- Zhang Fan
- Zhang Guo
- Zhang Guo-Chang
- Zhang Hao
- Zhang Hong
- Zhang Hongbing
- Zhang Jian
- Zhang Jiangwei
- Zhang Jianhua
- Zhang Jing-Pu
- Zhang Li
- Zhang Lin
- Zhang Long
- Zhang Ming-Yong
- Zhang Xiangnan
- Zhang Xu Dong
- Zhang Yan
- Zhang Yang
- Zhang Yanjin
- Zhang Yingmei
- Zhang Yunjiao
- Zhao Mei
- Zhao Wei-Li
- Zhao Xiaonan
- Zhao Yan G.
- Zhao Ying
- Zhao Yongchao
- Zhao Yu-Xia
- Zhao Zhendong
- Zhao Zhizhuang J.
- Zheng Dexian
- Zheng Xi-Long
- Zheng Xiaoxiang
- Zhivotovsky Boris
- Zhong Qing
- Zhou Guang-Zhou
- Zhou Guofei
- Zhou Huiping
- Zhou Shu-Feng
- Zhou Xu-Jie
- Zhu Hongxin
- Zhu Hua
- Zhu Wei-Guo
- Zhu Wenhua
- Zhu Xiao-Feng
- Zhu Yuhua
- Zhuang Shi-Mei
- Zhuang Xiaohong
- Ziparo Elio
- Zois Christos E.
- Zoladek Teresa
- Zong Wei-Xing
- Zorzano Antonio
- Zughaier Susu M.
- Publication venue
- 'Informa UK Limited'
- Publication date
- 01/01/2016
- Field of study
non present
Guidelines for the use and interpretation of assays for monitoring autophagy (3rd edition)
- Author
- Abdelmohsen Kotb
- Abe Akihisa
- Abedin Md Joynal
- Abeliovich Hagai
- Adachi Hiroaki
- Adams Christopher M.
- Adams Peter D.
- Adeli Khosrow
- Adhihetty Peter J.
- Adler Sharon G.
- Agam Galila
- Agarwal Rajesh
- Aghi Manish K.
- Agnello Maria
- Agostinis Patrizia
- Aguilar Patricia V.
- Aguirre-Ghiso Julio
- Airoldi Edoardo M.
- Ait-Si-Ali Slimane
- Akematsu Takahiko
- Akporiaye Emmanuel T.
- Al-Rubeai Mohamed
- Albaiceta Guillermo M.
- Albanese Chris
- Albani Diego
- Albert Matthew L.
- Aldudo Jesus
- Alguel Hana
- Alirezaei Mehrdad
- Alloza Iraide
- Almasan Alexandru
- Almonte-Beceril Maylin
- Alnemri Emad S.
- Alonso Covadonga
- Altan-Bonnet Nihal
- Altieri Dario C.
- Alvarez Silvia
- Alvarez-Erviti Lydia
- Alves Sandro
- Amadoro Giuseppina
- Amano Atsuo
- Amantini Consuelo
- Ambrosio Santiago
- Amelio Ivano
- Amer Amal O.
- Amessou Mohamed
- Amon Angelika
- An Zhenyi
- Ana Gonzalez-Polo Rosa
- Anania Frank A.
- Andersen Stig U.
- Andley Usha P.
- Andreadi Catherine K.
- Andrieu-Abadie Nathalie
- Anel Alberto
- Ann David K.
- Anoopkumar-Dukie Shailendra
- Antonioli Manuela
- Aoki Hiroshi
- Apostolova Nadezda
- Aquila Saveria
- Aquilano Katia
- Araki Koichi
- Arama Eli
- Aranda Agustin
- Araya Jun
- Arcaro Alexandre
- Arias Esperanza
- Arimoto Hirokazu
- Ariosa Aileen R.
- Armstrong Jane L.
- Arnould Thierry
- Arozena Abraham Acevedo
- Arsov Ivica
- Asanuma Katsuhiko
- Askanas Valerie
- Asselin Eric
- Atarashi Ryuichiro
- Atherton Sally S.
- Atkin Julie D.
- Attardi Laura D.
- Auberger Patrick
- Auburger Georg
- Aurelian Laure
- Autelli Riccardo
- Avagliano Laura
- Avantaggiati Maria Laura
- Avrahami Limor
- Awale Suresh
- Azad Neelam
- Bachetti Tiziana
- Backer Jonathan M.
- Bae Dong-Hun
- Bae Jae-Sung
- Bae Ok-Nam
- Bae Soo Han
- Baehrecke Eric H.
- Baek Seung-Hoon
- Baghdiguian Stephen
- Bagniewska-Zadworna Agnieszka
- Bai Hua
- Bai Jie
- Bai Xue-Yuan
- Bailly Yannick
- Balaji Kithiganahalli Narayanaswamy
- Balduini Walter
- Ballabio Andrea
- Balzan Rena
- Banerjee Rajkumar
- Banhegyi Gabor
- Bao Haijun
- Barbato Daniele Lettieri
- Barbeau Benoit
- Barrachina Maria D.
- Barreiro Esther
- Bartel Bonnie
- Bartolome Alberto
- Bassham Diane C.
- Bassi Maria Teresa
- Bast Robert C., Jr.
- Basu Alakananda
- Batista Maria Teresa
- Batoko Henri
- Battino Maurizio
- Bauckman Kyle
- Baumgarner Bradley L.
- Bayer K. Ulrich
- Beale Rupert
- Beaulieu Jean-Francois
- Beck George R., Jr.
- Becker Christoph
- Beckham J. David
- Bedard Pierre-Andre
- Bednarski Patrick J.
- Begley Thomas J.
- Behl Christian
- Behrends Christian
- Behrens Georg M. N.
- Behrns Kevin E.
- Bejarano Eloy
- Belaid Amine
- Belleudi Francesca
- Benard Giovanni
- Berchem Guy
- Bergamaschi Daniele
- Bergami Matteo
- Berkhout Ben
- Berliocchi Laura
- Bernard Amelie
- Bernard Monique
- Bernassola Francesca
- Bertolotti Anne
- Bess Amanda S.
- Besteiro Sebastien
- Bettuzzi Saverio
- Bhalla Savita
- Bhattacharyya Shalmoli
- Bhutia Sujit K.
- Biagosch Caroline
- Bianchi Michele Wolfe
- Biard-Piechaczyk Martine
- Billes Viktor
- Bincoletto Claudia
- Bingol Baris
- Bird Sara W.
- Bitoun Marc
- Bjedov Ivana
- Blackstone Craig
- Blanc Lionel
- Blanco Guillermo A.
- Blomhoff Heidi Kiil
- Boada-Romero Emilio
- Boeckler Stefan
- Boes Marianne
- Boesze-Battaglia Kathleen
- Boise Lawrence H.
- Bolino Alessandra
- Boman Andrea
- Bonaldo Paolo
- Bordi Matteo
- Bosch Jurgen
- Botana Luis M.
- Botti Joelle
- Bou German
- Bouche Marina
- Bouchecareilh Marion
- Boucher Marie-Josee
- Boulton Michael E.
- Bouret Sebastien G.
- Boya Patricia
- Boyer-Guittaut Michaeel
- Bozhkov Peter V.
- Brady Nathan
- Braga Vania M. M.
- Brancolini Claudio
- Braus Gerhard H.
- Bravo-San Pedro Jose M.
- Brennan Lisa A.
- Bresnick Emery H.
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- Zughaier Susu M.
- Publication venue
- Publication date
- 01/01/2016
- Field of study
Recommended from our members
Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
- Author
- Aagaard Bitten
- Accardi Evan
- ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group
- Adam Stacey J
- Adams Amy
- Agarwal Trisha
- Aggarwal Neil R
- Akbari Freshta
- Albert Sara
- Alexander Elizabeth
- Almasri Eyad
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- Amos Laura
- Amosu Omowunmi
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- Applegate Darrin
- Armbruster Brent P
- Arribas Jose R
- Ashktorab Kimia
- Ashok Kiran
- Aston Valerie T
- Audette Matthew
- Babiker Abdel G
- Badhwar Vinay
- Badrock Jonathan
- Baduashvili Amiran
- Bagiella Emilia
- Baio Kim T
- Baker Jason V
- Baker Rebecca
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- Balde Abby
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- Baracco Gio
- Baracz Michelle
- Barkauskas Christina E
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- Chang Steven Y
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- Chiu Joseph
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- Taddei-Peters Wendy C
- Talmor Daniel
- Terndrup Thomas E
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- Thiruchelvam Nirosshan
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- Thompson B. Taylor
- Thompson Greg
- Thorlacius-Ussing Louise
- Thornton Kara
- Thornton-Thompson Sherell
- Tidswell Mark A
- Tien Phyllis
- Tierney John
- Tinggaard Michaela
- Tipple Craig
- Tipton Gregory
- Torbati Sam S
- Touloumi Giota
- Towfighi Amytis
- Tran Sonny
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- Turner Melissa
- Tyler Derrick
- Tzehaie Hiwet
- Van John
- Vargas Julia
- Vasudeva Shikha
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- Villa Samantha
- Vincent Shelika
- Virachit Sophie
- Vjecha Michael
- Vock David M
- Voge Susan E
- Vojnik Rosemary
- von Huth Sebastian Leicht
- Vonderhaar Derek
- Wald-Dickler Noah
- Wallick Julie A
- Walski Jamie
- Wang Bonnie R
- Want Samantha
- Want Yiqun
- Watson Helen
- Watts Matthew
- Webb Brandon
- Weintrob Amy C
- Weissman Kevin
- Wenner Christine
- Wentworth Deborah
- West Emily
- Whitacre Heather
- Wiedemann Herbert P
- Wiese Lothar
- Williams Roger
- Willis Angela
- Wilson David M
- Wilson Jennifer G
- Witte Marie
- Woldbye Frederik
- Wyles David
- Wynter Timothy
- Yan Li
- Yee Kimberly J
- Yeo Tsin Wen
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- Zheng Yiling
- Zhong Amy
- Zhu Qing
- Zhuo Hanjing
- Zink Veronika
- Zuckerman Judith
- Zuckerman Richard A
- Østergaard Lars
- Publication venue
- Elsevier Ltd
- Publication date
- 01/05/2022
- Field of study
We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.
In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.
Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.
Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.
US National Institutes of Health and Operation Warp Spee