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3. A guide to immunotherapy for COVID-19

Author

Veerdonk, F.L. van de, Giamarellos-Bourboulis, E., Pickkers, P., Derde, L., Leavis, H., Crevel, R. van, Engel, J.J., Wiersinga, W.J., Vlaar, A.P.J., Shankar-Hari, M., Poll, T. van der, Bonten, M., Angus, D.C., Meer, J.W.M. van der, Netea, M.G., Veerdonk, F.L. van de, Giamarellos-Bourboulis, E., Pickkers, P., Derde, L., Leavis, H., Crevel, R. van, Engel, J.J., Wiersinga, W.J., Vlaar, A.P.J., Shankar-Hari, M., Poll, T. van der, Bonten, M., Angus, D.C., Meer, J.W.M. van der, and Netea, M.G.

Abstract

Item does not contain fulltext, Immune dysregulation is an important component of the pathophysiology of COVID-19. A large body of literature has reported the effect of immune-based therapies in patients with COVID-19, with some remarkable successes such as the use of steroids or anti-cytokine therapies. However, challenges in clinical decision-making arise from the complexity of the disease phenotypes and patient heterogeneity, as well as the variable quality of evidence from immunotherapy studies. This Review aims to support clinical decision-making by providing an overview of the evidence generated by major clinical trials of host-directed therapy. We discuss patient stratification and propose an algorithm to guide the use of immunotherapy strategies in the clinic. This will not only help guide treatment decisions, but may also help to design future trials that investigate immunotherapy in other severe infections.

Published
2022

4. The European clinical research response to optimise treatment of patients with COVID-19 : lessons learned, future perspective, and recommendations

Author

Goossens, H, Derde, L, Horby, P, and Bonten, M

Subjects
Europe, Personal View, Infectious Diseases, COVID-19, Humans, Human medicine, Pandemics, Disease Outbreaks
Abstract

Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during pandemics. We focused on two platform trials: RECOVERY and REMAP-CAP. Both trials were able to enrol patients very rapidly during the beginning of the pandemic because of pre-established structures and procedures, and because they share simple execution and flexibility to adjust when evidence emergences. However, contracting, regulatory hurdles, and competition with (often inadequately designed or underpowered) national trials was a major challenge in several EU countries. We recommend the creation of structures and partnerships that facilitate prioritisation of clinical research, simplification of clinical trial delivery, development of digital models and procedures for data collection and sharing, development of a mechanism to rapidly leverage pandemic funding and to connect EU funding with national funding, and investment in clinical trial networks, platform trials, and master protocols. Finally, the future pandemic clinical research response of the EU should be embedded in the global response. We believe that globally connected clinical trial networks will be essential to respond more effectively to future infectious diseases outbreaks.

Published
2022

5. Statement paper on diversity for the European Society of Intensive Care Medicine (ESICM)

Author

Weiss, Bjoern, Weiss, B., Prisco, L., Boulanger, C., Einav, S., Gruber, P., Laake, J. H., Mehta, S., Ostermann, M., Antonelli, M., Ben Nun, M., Bollen Pinto, B., Borkowska, M., Borthwick, M., Cecconi, M., Costa-Pinto, R., Derde, L. P. G., Forni, L. G., Galazzi, A., Girbes, A., Herridge, M., Hofsø, K., Juffermans, N. P., Kesecioglu, J., Lobo-Valbuena, B., Machado, F. R., Mekontso Dessap, A., Metaxa, V., Myatra, S. N., Olusanya, O., Rosenthal, M., Rygård, S. L., Schaller, S. J., Underman, K., Wade, D. M., Intensive Care Medicine, Intensive care medicine, and ACS - Diabetes & metabolism

Subjects
Male, medicine.medical_specialty, Critical Care, media_common.quotation_subject, Culture, Ethnic group, Critical Care and Intensive Care Medicine, 03 medical and health sciences, Politics, 0302 clinical medicine, Sex Factors, NOMINATE, medicine, Humans, Intensive care medicine, Society, Minority Groups, Societies, Medical, media_common, Diversity, business.industry, 030208 emergency & critical care medicine, Cultural Diversity, Identification (information), 030228 respiratory system, Socioeconomic Factors, Sexual orientation, What's New in Intensive Care, Female, Element (criminal law), Working group, business, Diversity (politics)
Abstract

Introduction Diversity has become a key-strategic element of success in various political and economic fields. The European Society of Intensive Care Medicine (ESICM) decided to make diversity a key strategic priority for the future and appointed a Task-Force on this topic. Methods In a consensus process, three Working-Groups, nominated by Task-Force members, developed statements on strategic future topics. In addition, diversity-related data available from the membership database have been analyzed and reported in aggregated form. Results The Task-Force decided to nominate working groups on (1) “sex, gender identity and sexual orientation”, (2) “ethnicity, culture and socio-economic status”, and (3) “multiprofessionalism”. These are the first prioritized topics for the near future. The first diversity-report shows targetable items in all three domains. Conclusion The diversity Task-Force defined actionable items for a one- and three-year plan that are especially aiming at the identification of potential gaps and an implementation of concrete projects for members of the ESICM. Electronic supplementary material The online version of this article (10.1007/s00134-019-05606-0) contains supplementary material, which is available to authorized users.

Published
2019

6. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial

Author

Estcourt, L.J., Turgeon, A.F., McQuilten, Z.K., McVerry, B.J., Al-Beidh, F., Annane, D., Arabi, Y.M., Arnold, D.M., Beane, A., Bégin, P., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Birchall, J.E., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Callum, J.L., Chassé, M., Cheng, A.C., Cove, M.E., Daly, J., Derde, L., Detry, M.A., Jong, Menno de, Evans, A., Fergusson, D.A., Fish, M., Fitzgerald, M., Foley, C., Goossens, H., Gordon, A.C., Gosbell, I.B., Green, C., Haniffa, R., Harvala, H., Higgins, A.M., Hills, T.E., Hoad, V.C., Horvat, C., Huang, D.T., Hudson, C.L., Ichihara, N., Laing, E., Lamikanra, A.A., Lamontagne, F., Lawler, P.R., Linstrum, K., Litton, E., Lorenzi, E., MacLennan, S., Marshall, J., McAuley, D.F., McDyer, J.F., McGlothlin, A., McGuinness, S., Miflin, G., Montgomery, S., Mouncey, P.R., Murthy, S., Nichol, A., Parke, R., Parker, J.C., Priddee, N., Purcell, D.F.J., Reyes, L.F., Richardson, P., Robitaille, N., Rowan, K.M., Rynne, J., Saito, H., Santos, M., Saunders, C.T., Neto, A. Serpa, Seymour, C.W., Silversides, J.A., Tinmouth, A.A., Triulzi, D.J., Turner, A.M., Veerdonk, F.L. van de, Walsh, T.S., Wood, E.M., Berry, S., Lewis, R.J., Menon, D.K., McArthur, C., Zarychanski, R., Angus, D.C., Webb, S.A., Roberts, D.J., Shankar-Hari, M., Estcourt, L.J., Turgeon, A.F., McQuilten, Z.K., McVerry, B.J., Al-Beidh, F., Annane, D., Arabi, Y.M., Arnold, D.M., Beane, A., Bégin, P., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Birchall, J.E., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Callum, J.L., Chassé, M., Cheng, A.C., Cove, M.E., Daly, J., Derde, L., Detry, M.A., Jong, Menno de, Evans, A., Fergusson, D.A., Fish, M., Fitzgerald, M., Foley, C., Goossens, H., Gordon, A.C., Gosbell, I.B., Green, C., Haniffa, R., Harvala, H., Higgins, A.M., Hills, T.E., Hoad, V.C., Horvat, C., Huang, D.T., Hudson, C.L., Ichihara, N., Laing, E., Lamikanra, A.A., Lamontagne, F., Lawler, P.R., Linstrum, K., Litton, E., Lorenzi, E., MacLennan, S., Marshall, J., McAuley, D.F., McDyer, J.F., McGlothlin, A., McGuinness, S., Miflin, G., Montgomery, S., Mouncey, P.R., Murthy, S., Nichol, A., Parke, R., Parker, J.C., Priddee, N., Purcell, D.F.J., Reyes, L.F., Richardson, P., Robitaille, N., Rowan, K.M., Rynne, J., Saito, H., Santos, M., Saunders, C.T., Neto, A. Serpa, Seymour, C.W., Silversides, J.A., Tinmouth, A.A., Triulzi, D.J., Turner, A.M., Veerdonk, F.L. van de, Walsh, T.S., Wood, E.M., Berry, S., Lewis, R.J., Menon, D.K., McArthur, C., Zarychanski, R., Angus, D.C., Webb, S.A., Roberts, D.J., and Shankar-Hari, M.

Abstract

Item does not contain fulltext, IMPORTANCE: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. OBJECTIVE: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONS: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURES: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromb

Published
2021

7. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients with COVID-19: A Randomized Clinical Trial.

Author

Estcourt L.J., Turgeon A.F., McQuilten Z.K., McVerry B.J., Al-Beidh F., Annane D., Arabi Y.M., Arnold D.M., Beane A., Begin P., Van Bentum-Puijk W., Berry L.R., Bhimani Z., Birchall J.E., Bonten M.J.M., Bradbury C.A., Brunkhorst F.M., Buxton M., Callum J.L., Chasse M., Cheng A.C., Cove M.E., Daly J., Derde L., Detry M.A., De Jong M., Evans A., Fergusson D.A., Fish M., Fitzgerald M., Foley C., Goossens H., Gordon A.C., Gosbell I.B., Green C., Haniffa R., Harvala H., Higgins A.M., Hills T.E., Hoad V.C., Horvat C., Huang D.T., Hudson C.L., Ichihara N., Laing E., Lamikanra A.A., Lamontagne F., Lawler P.R., Linstrum K., Litton E., Lorenzi E., Maclennan S., Marshall J., McAuley D.F., McDyer J.F., McGlothlin A., McGuinness S., Miflin G., Montgomery S., Mouncey P.R., Murthy S., Nichol A., Parke R., Parker J.C., Priddee N., Purcell D.F.J., Reyes L.F., Richardson P., Robitaille N., Rowan K.M., Rynne J., Saito H., Santos M., Saunders C.T., Serpa Neto A., Seymour C.W., Silversides J.A., Tinmouth A.A., Triulzi D.J., Turner A.M., Van De Veerdonk F., Walsh T.S., Wood E.M., Berry S., Lewis R.J., Menon D.K., McArthur C., Zarychanski R., Angus D.C., Webb S.A., Roberts D.J., Shankar-Hari M., Estcourt L.J., Turgeon A.F., McQuilten Z.K., McVerry B.J., Al-Beidh F., Annane D., Arabi Y.M., Arnold D.M., Beane A., Begin P., Van Bentum-Puijk W., Berry L.R., Bhimani Z., Birchall J.E., Bonten M.J.M., Bradbury C.A., Brunkhorst F.M., Buxton M., Callum J.L., Chasse M., Cheng A.C., Cove M.E., Daly J., Derde L., Detry M.A., De Jong M., Evans A., Fergusson D.A., Fish M., Fitzgerald M., Foley C., Goossens H., Gordon A.C., Gosbell I.B., Green C., Haniffa R., Harvala H., Higgins A.M., Hills T.E., Hoad V.C., Horvat C., Huang D.T., Hudson C.L., Ichihara N., Laing E., Lamikanra A.A., Lamontagne F., Lawler P.R., Linstrum K., Litton E., Lorenzi E., Maclennan S., Marshall J., McAuley D.F., McDyer J.F., McGlothlin A., McGuinness S., Miflin G., Montgomery S., Mouncey P.R., Murthy S., Nichol A., Parke R., Parker J.C., Priddee N., Purcell D.F.J., Reyes L.F., Richardson P., Robitaille N., Rowan K.M., Rynne J., Saito H., Santos M., Saunders C.T., Serpa Neto A., Seymour C.W., Silversides J.A., Tinmouth A.A., Triulzi D.J., Turner A.M., Van De Veerdonk F., Walsh T.S., Wood E.M., Berry S., Lewis R.J., Menon D.K., McArthur C., Zarychanski R., Angus D.C., Webb S.A., Roberts D.J., and Shankar-Hari M.

Abstract

Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. Objective(s): To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. Design, Setting, and Participant(s): The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. Intervention(s): The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL +/- 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). Main Outcomes and Measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; veno

Published
2021

8. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update

Author

Alhazzani, W, Evans, L, Alshamsi, F, Møller, M, Ostermann, M, Prescott, H, Arabi, Y, Loeb, M, Ng Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Machado, F, Wunsch, H, Crowther, M, Cecconi, M, Koh, Y, Burry, L, Chertow, D, Szczeklik, W, Belley-Cote, E, Greco, M, Bala, M, Zarychanski, R, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Nainan Myatra, S, Arrington, A, Kleinpell, R, Citerio, G, Lewis, K, Bridges, E, Memish, Z, Hammond, N, Hayden, F, Alshahrani, M, Al Duhailib, Z, Martin, G, Kaplan, L, Coopersmith, C, Antonelli, M, Rhodes, A, Alhazzani, Waleed, Evans, Laura, Alshamsi, Fayez, Møller, Morten Hylander, Ostermann, Marlies, Prescott, Hallie C., Arabi, Yaseen M., Loeb, Mark, Ng Gong, Michelle, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Machado, Flavia, Wunsch, Hannah, Crowther, Mark, Cecconi, Maurizio, Koh, Younsuck, Burry, Lisa, Chertow, Daniel S., Szczeklik, Wojciech, Belley-Cote, Emilie, Greco, Massimiliano, Bala, Malgorzata, Zarychanski, Ryan, Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Nainan Myatra, Sheila, Arrington, Amy, Kleinpell, Ruth, Citerio, Giuseppe, Lewis, Kimberley, Bridges, Elizabeth, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Alshahrani, Muhammed, Al Duhailib, Zainab, Martin, Greg S., Kaplan, Lewis J., Coopersmith, Craig M., Antonelli, Massimo, Rhodes, Andrew, Alhazzani, W, Evans, L, Alshamsi, F, Møller, M, Ostermann, M, Prescott, H, Arabi, Y, Loeb, M, Ng Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Machado, F, Wunsch, H, Crowther, M, Cecconi, M, Koh, Y, Burry, L, Chertow, D, Szczeklik, W, Belley-Cote, E, Greco, M, Bala, M, Zarychanski, R, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Nainan Myatra, S, Arrington, A, Kleinpell, R, Citerio, G, Lewis, K, Bridges, E, Memish, Z, Hammond, N, Hayden, F, Alshahrani, M, Al Duhailib, Z, Martin, G, Kaplan, L, Coopersmith, C, Antonelli, M, Rhodes, A, Alhazzani, Waleed, Evans, Laura, Alshamsi, Fayez, Møller, Morten Hylander, Ostermann, Marlies, Prescott, Hallie C., Arabi, Yaseen M., Loeb, Mark, Ng Gong, Michelle, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Machado, Flavia, Wunsch, Hannah, Crowther, Mark, Cecconi, Maurizio, Koh, Younsuck, Burry, Lisa, Chertow, Daniel S., Szczeklik, Wojciech, Belley-Cote, Emilie, Greco, Massimiliano, Bala, Malgorzata, Zarychanski, Ryan, Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Nainan Myatra, Sheila, Arrington, Amy, Kleinpell, Ruth, Citerio, Giuseppe, Lewis, Kimberley, Bridges, Elizabeth, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Alshahrani, Muhammed, Al Duhailib, Zainab, Martin, Greg S., Kaplan, Lewis J., Coopersmith, Craig M., Antonelli, Massimo, and Rhodes, Andrew

Abstract

BACKGROUND: The coronavirus disease 2019 pandemic continues to affect millions worldwide. Given the rapidly growing evidence base, we implemented a living guideline model to provide guidance on the management of patients with severe or critical coronavirus disease 2019 in the ICU. METHODS: The Surviving Sepsis Campaign Coronavirus Disease 2019 panel has expanded to include 43 experts from 14 countries; all panel members completed an electronic conflict-of-interest disclosure form. In this update, the panel addressed nine questions relevant to managing severe or critical coronavirus disease 2019 in the ICU. We used the World Health Organization's definition of severe and critical coronavirus disease 2019. The systematic reviews team searched the literature for relevant evidence, aiming to identify systematic reviews and clinical trials. When appropriate, we performed a random-effects meta-analysis to summarize treatment effects. We assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach, then used the evidence-to-decision framework to generate recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. RESULTS: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued nine statements (three new and six updated) related to ICU patients with severe or critical coronavirus disease 2019. For severe or critical coronavirus disease 2019, the panel strongly recommends using systemic corticosteroids and venous thromboprophylaxis but strongly recommends against using hydroxychloroquine. In addition, the panel suggests using dexamethasone (compared with other corticosteroids) and suggests against using convalescent plasma and therapeutic anticoagulation outside clinical trials. The Surviving Sepsis Campaign Coronavirus Diease 2019 panel suggests using remdesivir in nonventilated patients with severe coronavirus disease 2019 and suggests again

Published
2021

9. The randomized embedded multifactorial adaptive platform for community-acquired pneumonia (REMAP-CAP) study: rationale and design

Author

Angus, DC, Berry, S, Lewis, RJ, Al-Beidh, F, Arabi, Y, Van Bentum-Puijk, W, Bhimani, Z, Bonten, M, Broglio, K, Brunkhorst, F, Cheng, AC, Chiche, J-D, De Jong, M, Detry, M, Goossens, H, Gordon, A, Green, C, Higgins, AM, Hullegie, SJ, Kruger, P, Lamontagne, F, Litton, E, Marshall, J, McGlothlin, A, McGuinness, S, Mouncey, P, Murthy, S, Nichol, A, O'Neill, GK, Parke, R, Parker, J, Rohde, G, Rowan, K, Turner, A, Young, P, Derde, L, McArthur, C, Webb, SA, and NIHR

Subjects
Respiratory System, 1103 Clinical Sciences
Abstract

There is broad interest in improved methods to generate robust evidence regarding best practice, especially in settings where patient conditions are heterogenous and require multiple concomitant therapies. Here, we present the rationale and design of a large, international trial that combines features of adaptive platform trials with pragmatic point-of-care trials to determine best treatment strategies for patients admitted to an intensive care unit with severe community-acquired pneumonia (CAP). The trial uses a novel design entitled a randomized embedded multifactorial adaptive platform (REMAP). The design has 5 key features: i.) randomization, allowing robust causal inference; ii.) embedding of study procedures into routine care processes, facilitating enrollment, trial efficiency, and generalizability; iii.) a multifactorial statistical model comparing multiple interventions across multiple patient subgroups; iv.) response-adaptive randomization with preferential assignment to those interventions that appear most favorable, and v.) a platform structured to permit continuous, potentially perpetual enrollment beyond the evaluation of the initial treatments. The trial randomizes patients to multiple interventions within 4 treatment domains: antibiotics, antiviral therapy for influenza, host immunomodulation with extended macrolide therapy, and alternative corticosteroid regimens, representing 240 treatment regimens. The trial generates estimates of superiority, inferiority and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection. The trial will also compare ventilatory and oxygenation strategies and has capacity to address additional questions rapidly during pandemic respiratory infections. As of January 2020, REMAP-CAP was approved and enrolling patients in 52 ICUs in 13 countries in 3 continents. In February, it transitioned into pandemic mode with several design adaptations for COVID-19 disease. Lessons learned from the design and conduct of this trial should aid in dissemination of similar platform initiatives in other disease areas. Clinical trial registered with ClinicalTrials.gov (NCT02735707)

Published
2020

10. Effect of hydrocortisone on mortality and organ support in patients with severe COVID-19: the REMAP-CAP COVID-19 corticosteroid domain randomized clinical trial

Author

Angus, DC, Derde, L, Al-Beidh, F, Annane, D, Arabi, Y, Beane, A, Van Bentum-Puijk, W, Berry, L, Bhimani, Z, Bonten, M, Bradbury, C, Brunkhorst, F, Buxton, M, Buzgau, A, Cheng, AC, De Jong, M, Detry, M, Estcourt, L, Fitzgerald, M, Goossens, H, Green, C, Haniffa, R, Higgins, AM, Horvat, C, Hullegie, SJ, Kruger, P, Lamontagne, F, Lawler, PR, Linstrum, K, Litton, E, Lorenzi, E, Marshall, J, McAuley, D, McGlothin, A, McGuinness, S, McVerry, B, Montgomery, S, Mouncey, P, Murthy, S, Nichol, A, Parke, R, Parker, J, Rowan, K, Sanil, A, Santos, M, Saunders, C, Seymour, C, Turner, A, Van De Veerdonk, F, Venkatesh, B, Zarychanski, R, Berry, S, Lewis, RJ, McArthur, C, Webb, SA, Gordon, AC, Orford, Neil, Angus, DC, Derde, L, Al-Beidh, F, Annane, D, Arabi, Y, Beane, A, Van Bentum-Puijk, W, Berry, L, Bhimani, Z, Bonten, M, Bradbury, C, Brunkhorst, F, Buxton, M, Buzgau, A, Cheng, AC, De Jong, M, Detry, M, Estcourt, L, Fitzgerald, M, Goossens, H, Green, C, Haniffa, R, Higgins, AM, Horvat, C, Hullegie, SJ, Kruger, P, Lamontagne, F, Lawler, PR, Linstrum, K, Litton, E, Lorenzi, E, Marshall, J, McAuley, D, McGlothin, A, McGuinness, S, McVerry, B, Montgomery, S, Mouncey, P, Murthy, S, Nichol, A, Parke, R, Parker, J, Rowan, K, Sanil, A, Santos, M, Saunders, C, Seymour, C, Turner, A, Van De Veerdonk, F, Venkatesh, B, Zarychanski, R, Berry, S, Lewis, RJ, McArthur, C, Webb, SA, Gordon, AC, and Orford, Neil

Published
2020

11. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19)

Author

Alhazzani, W, Møller, M, Arabi, Y, Loeb, M, Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Aboodi, M, Wunsch, H, Cecconi, M, Koh, Y, Chertow, D, Maitland, K, Alshamsi, F, Belley-Cote, E, Greco, M, Laundy, M, Morgan, J, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Alexander, P, Arrington, A, Centofanti, J, Citerio, G, Baw, B, Memish, Z, Hammond, N, Hayden, F, Evans, L, Rhodes, A, Alhazzani, Waleed, Møller, Morten Hylander, Arabi, Yaseen M., Loeb, Mark, Gong, Michelle Ng, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Aboodi, Michael, Wunsch, Hannah, Cecconi, Maurizio, Koh, Younsuck, Chertow, Daniel S., Maitland, Kathryn, Alshamsi, Fayez, Belley-Cote, Emilie, Greco, Massimiliano, Laundy, Matthew, Morgan, Jill S., Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Alexander, Paul E., Arrington, Amy, Centofanti, John E., Citerio, Giuseppe, Baw, Bandar, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Evans, Laura, Rhodes, Andrew, Alhazzani, W, Møller, M, Arabi, Y, Loeb, M, Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Aboodi, M, Wunsch, H, Cecconi, M, Koh, Y, Chertow, D, Maitland, K, Alshamsi, F, Belley-Cote, E, Greco, M, Laundy, M, Morgan, J, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Alexander, P, Arrington, A, Centofanti, J, Citerio, G, Baw, B, Memish, Z, Hammond, N, Hayden, F, Evans, L, Rhodes, A, Alhazzani, Waleed, Møller, Morten Hylander, Arabi, Yaseen M., Loeb, Mark, Gong, Michelle Ng, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Aboodi, Michael, Wunsch, Hannah, Cecconi, Maurizio, Koh, Younsuck, Chertow, Daniel S., Maitland, Kathryn, Alshamsi, Fayez, Belley-Cote, Emilie, Greco, Massimiliano, Laundy, Matthew, Morgan, Jill S., Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Alexander, Paul E., Arrington, Amy, Centofanti, John E., Citerio, Giuseppe, Baw, Bandar, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Evans, Laura, and Rhodes, Andrew

Abstract

Background: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. Methods: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. Results: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which four are best practice statements, nine are strong recommendations, and 35 are weak recommendations. No recommendation was provided for six questions. The topics were: 1) infection control, 2) laboratory diagnosis and specimens, 3) hemodynamic support, 4) ventilatory support, and 5) COVID-19 therapy. Conclusion: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new evidence in further releases of these guidelines.

Published
2020

16. Molecular epidemiology of MRSA in 13 ICUs from eight European countries

Author

Hetem, D. J., Derde, L. P G, Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, M. J M, Cooper, B., Malhotra-Kumar, S., Willems, R., Gniadkowski, M., Dautzenberg, M., Annane, D., Aragão, I., Chalfine, A., Dumpis, U., Esteves, F., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G., Tomic, V., Torres Martí, A., Stammet, P., Brun-Buisson, C., Aires, E., Antoniadou, A., Armaganidis, A., Blairon, F., Carneiro, J., Chaskou, D., Coppadoro, P., Dias, A. P., Drinovec, I., Elia, M., Exarchou, V., Flet, A., Fournier, J., Gillet, N., Jaklič, A., Jereb, M., Kane, A., Karkali, E., Kieffer, J., Kirpach, P., Landelle, C., Landercy, F., Lawrence, C., Legrand, P., Lopes, V., Magira, E., Marco, F., Martínez, J. A., Melbarde-Kelmere, A., Misset, B., Monte, R., Moreno, E., Nguyen, J. C., Novak, M., Orazi, D., Papadomichelakis, E., Papaparaskevas, J., Paris, M., Pavleas, J., Pimenta, F., Piñer, R., Radouan, A., Ramunno, M. G., Reis, M., Rinaldi, I., Ronco, E., San Jose, A., Seme, K., Skiada, A., Trapassi, S., Tronci, M., Verachten, M., Vila, J., Vrankar, K., Winkler, M., Zagavierou, S., Hopman, M., Leus, F., Schotsman, J., Zwerver, J., and MOSAR WP3 Study Grp

Subjects
Male, Methicillin-Resistant Staphylococcus aureus, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Pediatrics, Genotype, 030106 microbiology, medicine.disease_cause, Staphylococcal infections, law.invention, 03 medical and health sciences, law, Internal medicine, Epidemiology, Journal Article, Humans, Medicine, Pharmacology (medical), Typing, Biology, Aged, Aged, 80 and over, Medicine(all), Pharmacology, Cross Infection, Molecular Epidemiology, Molecular epidemiology, business.industry, SCCmec, Pharmacology. Therapy, Staphylococcal Infections, biochemical phenomena, metabolism, and nutrition, medicine.disease, bacterial infections and mycoses, Methicillin-resistant Staphylococcus aureus, Intensive care unit, Europe, Molecular Typing, Intensive Care Units, Nasal Mucosa, Infectious Diseases, Wounds and Injuries, Multilocus sequence typing, Female, Human medicine, business
Abstract

Objectives: Rigorous screening of carriage of MRSA, rather than relying on clinical isolates, together with standardized methods and centralized genotyping allowed for a more comprehensive and complete estimation of the prevalence and epidemiology of the isolates in the ICUs involved in the study.The European epidemiology of MRSA is changing with the emergence of community-associated MRSA (CA-MRSA) and livestock-associated MRSA (LA-MRSA). In this study, we investigated the molecular epidemiology of MRSA during 2 years in 13 ICUs in France, Greece, Italy, Latvia, Luxemburg, Portugal, Slovenia and Spain. Methods: Surveillance cultures for MRSA from nose and wounds were obtained on admission and twice weekly from all patients admitted to an ICU for >= 3 days. The first MRSA isolate per patient was genotyped in a central laboratory by MLST, spa typing, agr typing and SCCmec (sub)typing. Risk factors for patients with an unknown history of MRSA colonization were identified. Results: Overall, 14aEuroS390 ICU patients were screened, of whom 8519 stayed in an ICU for >= 3 days. Overall MRSA admission prevalence was 3.9% and ranged from 1.0% to 7.0% for individual ICUs. Overall MRSA acquisition rate was 2.5/1000 patient days at risk and ranged from 0.2 to 8/1000 patient days at risk per ICU. In total, 557 putative MRSA isolates were submitted to the central laboratory for typing, of which 511 (92%) were confirmed as MRSA. Each country had a distinct epidemiology, with ST8-IVc (UK-EMRSA-2/-6, USA500) being most prevalent, especially in France and Spain, and detected in ICUs in five of eight countries. Seventeen (3%) and three (< 1%) isolates were categorized as CA-MRSA and LA-MRSA, respectively. Risk factors for MRSA carriage on ICU admission were age > 70 years and hospitalization within 1 year prior to ICU admission. Conclusions: The molecular epidemiology of MRSA in 13 European ICUs in eight countries was homogeneous within, but heterogeneous between, countries. CA-MRSA and LA-MRSA genotypes and Panton-Valentine leucocidin-producing isolates were detected sporadically.

Published
2016

17. Phylogenetic lineages, clones and β-lactamases in an international collection of Klebsiella oxytoca isolates non-susceptible to expanded-spectrum cephalosporins

Author

Izdebski, R., Fiett, J., Urbanowicz, P., Baraniak, A., Derde, L. P G, Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Brisse, S., Gniadkowski, M., Herda, M., Dautzenberg, M. J., Adler, A., Kazma, M., Navon-Venezia, S., Malhotra-Kumar, S., Lammens, C., Legrand, P., Chalfine, A., Giamarellou, H., Petrikkos, G. L., Balode, A., Dumpis, U., Stammet, P., Aragăo, I., Esteves, F., Torres Martí, A., Lawrence, C., Salomon, J., Paul, M., Lerman, Y., Rossini, A., Salvia, A., Vidal Samso, J., and Fierro, J.

Subjects
Microbiology (medical), Genotype, Lineage (evolution), Microbial Sensitivity Tests, Research Support, Polymerase Chain Reaction, beta-Lactam Resistance, beta-Lactamases, Microbiology, Feces, Phylogenetics, Pulsed-field gel electrophoresis, Journal Article, Humans, Pharmacology (medical), Israel, Non-U.S. Gov't, Biology, Phylogeny, Medicine(all), Pharmacology, Phylogenetic tree, biology, Pharmacology. Therapy, Research Support, Non-U.S. Gov't, Klebsiella oxytoca, Genetic Variation, Sequence Analysis, DNA, biochemical phenomena, metabolism, and nutrition, biology.organism_classification, bacterial infections and mycoses, Hospitals, Anti-Bacterial Agents, Cephalosporins, Klebsiella Infections, Europe, Molecular Typing, Phylogenetic diversity, Infectious Diseases, Carrier State, Multilocus sequence typing, Human medicine
Abstract

Objectives The objective of this study was to examine Klebsiella oxytoca clonal and phylogenetic diversity, based on an international collection of carriage isolates non-susceptible to expanded-spectrum cephalosporins (ESCs). Methods The study material comprised 68 rectal carriage K. oxytoca isolates non-susceptible to ESCs recovered in 200811 from patients in 14 hospitals across Europe and Israel. ESC resistance was tested phenotypically; genes encoding ESBLs, AmpC cephalosporinases and carbapenemases were amplified and sequenced. The isolates were typed by PFGE and MLST, followed by sequencing of blaOXY genes. Results MLST and PFGE distinguished 34 STs and 47 pulsotypes among the isolates, respectively. Six STs were split into several pulsotypes each. Five STs were more prevalent (n = 29) and occurred in several countries each, including ST2, ST9 and ST141, which belong to a growing international clonal complex (CC), CC2. Four phylogenetic lineages were distinguished, each with another type of chromosomal OXY-type β-lactamase. Three of these, with OXY-1/-5, OXY-2 types and OXY-4, corresponded to previously described phylogroups KoI, KoII and KoIV, respectively. A single isolate from Israel represented a distinct lineage with a newly defined OXY-7 type. The phylogroups showed interesting differences in mechanisms of ESC resistance; KoI strains rarely overexpressed the OXY enzymes but commonly produced ESBLs, whereas KoII strains often were OXY hyperproducers and carried ESBLs much less frequently. AmpCs (DHA-1) and carbapenemases (VIM-1) occurred sporadically. Conclusions The study confirmed the high genetic diversity of the collection of K. oxytoca ESC-non-susceptible isolates, composed of phylogroups with distinct types of OXY-type β-lactamases, and revealed some STs of broad geographical distribution.

Published
2015

18. KPC-like carbapenemase-producing enterobacteriaceae colonizing patients in Europe and Israel

Author

Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., and Gniadkowski, M.

Published
2016

19. KPC-like carbapenemase-producing enterobacteriaceae colonizing patients in Europe and Israel

Author

UMC Utrecht, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., UMC Utrecht, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., and Gniadkowski, M.

Published
2016

20. Molecular epidemiology of MRSA in 13 ICUs from eight European countries

Author

MMB opleiding Arts microbioloog, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, MMB Research line 2, Epi Infectieziekten Team 1, Datamanagement 1, Hetem, D. J., Derde, L. P G, Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, M. J M, Cooper, B., Malhotra-Kumar, S., Willems, R., Gniadkowski, M., Dautzenberg, M., Annane, D., Aragão, I., Chalfine, A., Dumpis, U., Esteves, F., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G., Tomic, V., Torres Martí, A., Stammet, P., Brun-Buisson, C., Aires, E., Antoniadou, A., Armaganidis, A., Blairon, F., Carneiro, J., Chaskou, D., Coppadoro, P., Dias, A. P., Drinovec, I., Elia, M., Exarchou, V., Flet, A., Fournier, J., Gillet, N., Jaklič, A., Jereb, M., Kane, A., Karkali, E., Kieffer, J., Kirpach, P., Landelle, C., Landercy, F., Lawrence, C., Legrand, P., Lopes, V., Magira, E., Marco, F., Martínez, J. A., Melbarde-Kelmere, A., Misset, B., Monte, R., Moreno, E., Nguyen, J. C., Novak, M., Orazi, D., Papadomichelakis, E., Papaparaskevas, J., Paris, M., Pavleas, J., Pimenta, F., Piñer, R., Radouan, A., Ramunno, M. G., Reis, M., Rinaldi, I., Ronco, E., San Jose, A., Seme, K., Skiada, A., Trapassi, S., Tronci, M., Verachten, M., Vila, J., Vrankar, K., Winkler, M., Zagavierou, S., Hopman, M., Leus, F., Schotsman, J., Zwerver, J., MMB opleiding Arts microbioloog, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, MMB Research line 2, Epi Infectieziekten Team 1, Datamanagement 1, Hetem, D. J., Derde, L. P G, Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, M. J M, Cooper, B., Malhotra-Kumar, S., Willems, R., Gniadkowski, M., Dautzenberg, M., Annane, D., Aragão, I., Chalfine, A., Dumpis, U., Esteves, F., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G., Tomic, V., Torres Martí, A., Stammet, P., Brun-Buisson, C., Aires, E., Antoniadou, A., Armaganidis, A., Blairon, F., Carneiro, J., Chaskou, D., Coppadoro, P., Dias, A. P., Drinovec, I., Elia, M., Exarchou, V., Flet, A., Fournier, J., Gillet, N., Jaklič, A., Jereb, M., Kane, A., Karkali, E., Kieffer, J., Kirpach, P., Landelle, C., Landercy, F., Lawrence, C., Legrand, P., Lopes, V., Magira, E., Marco, F., Martínez, J. A., Melbarde-Kelmere, A., Misset, B., Monte, R., Moreno, E., Nguyen, J. C., Novak, M., Orazi, D., Papadomichelakis, E., Papaparaskevas, J., Paris, M., Pavleas, J., Pimenta, F., Piñer, R., Radouan, A., Ramunno, M. G., Reis, M., Rinaldi, I., Ronco, E., San Jose, A., Seme, K., Skiada, A., Trapassi, S., Tronci, M., Verachten, M., Vila, J., Vrankar, K., Winkler, M., Zagavierou, S., Hopman, M., Leus, F., Schotsman, J., and Zwerver, J.

Published
2016

22. Survey of metallo-beta-lactamase-producing Enterobacteriaceae colonizing patients in European ICUs and rehabilitation units, 2008-11

Author

Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., MOSAR WP2 WP3 WP5 Study Grp, Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., and MOSAR WP2 WP3 WP5 Study Grp

Published
2015

23. MLST reveals potentially high-risk international clones of Enterobacter cloacae

Author

Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P G, Dautzenberg, M. J., Adler, A., Kazma, M., Navon-venezia, S., Malhotra-kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., Lerman, Y., Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P G, Dautzenberg, M. J., Adler, A., Kazma, M., Navon-venezia, S., Malhotra-kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., and Lerman, Y.

Published
2015

24. MLST reveals potentially high-risk international clones of Enterobacter cloacae

Author

Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P G, Dautzenberg, M. J., Adler, A., Kazma, M., Navon-venezia, S., Malhotra-kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., Lerman, Y., Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P G, Dautzenberg, M. J., Adler, A., Kazma, M., Navon-venezia, S., Malhotra-kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., and Lerman, Y.

Published
2015

25. Survey of metallo-beta-lactamase-producing Enterobacteriaceae colonizing patients in European ICUs and rehabilitation units, 2008-11

Author

Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., MOSAR WP2 WP3 WP5 Study Grp, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., and MOSAR WP2 WP3 WP5 Study Grp

Published
2015

27. KPC-Like Carbapenemase-Producing EnterobacteriaceaeColonizing Patients in Europe and Israel

Author

Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P. G., Bonten, M. J. M., Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., and Gniadkowski, M.

Abstract

ABSTRACTIn a 2008-2011 survey, 17,945 patients in 18 hospital units in Europe and Israel were screened for carriage of Klebsiella pneumoniaecarbapenemase (KPC)-producing Enterobacteriaceae, resulting in identification of 124 positive patients. The isolates were dominated by Klebsiella pneumoniaesequence type 258 (ST258) KPC-2 and ST512 KPC-3, mainly from Greece and Italy, respectively, whereas Israeli isolates were of diverse species, clones, and KPC variants. Various blaKPCplatforms were observed, among which IncFIIK-FIBKplasmids with blaKPC-2/-3genes in the Tn4401a transposon prevailed.

Published
2016
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28. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19)

Author

Andrew Rhodes, Michael S. Aboodi, Eddy Fan, Waleed Alhazzani, Jill S. Morgan, Massimiliano Greco, Paul E. Alexander, Amy L. Dzierba, Lennie P. G. Derde, Mark Loeb, Maurizio Cecconi, Kathryn Maitland, Amy S. Arrington, Leonard A. Mermel, Bandar Baw, Daniel S. Chertow, Simon Oczkowski, John Centofanti, Ziad A. Memish, Michelle Ng Gong, Manoj J. Mammen, Laura Evans, Younsuck Koh, Yaseen M. Arabi, Hannah Wunsch, Bin Du, Naomi E Hammond, Frederick G Hayden, Matthew Laundy, Allison McGeer, Giuseppe Citerio, Morten Hylander Møller, Jozef Kesecioglu, Emilie P. Belley-Côté, Fayez Alshamsi, Mitchell M. Levy, Alhazzani, W, Møller, M, Arabi, Y, Loeb, M, Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Aboodi, M, Wunsch, H, Cecconi, M, Koh, Y, Chertow, D, Maitland, K, Alshamsi, F, Belley-Cote, E, Greco, M, Laundy, M, Morgan, J, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Alexander, P, Arrington, A, Centofanti, J, Citerio, G, Baw, B, Memish, Z, Hammond, N, Hayden, F, Evans, L, and Rhodes, A

Subjects
medicine.medical_specialty, Surviving Sepsis Campaign, Best practice, Coronaviru, MEDLINE, SARS CoV-2, 1110 Nursing, Critical Care and Intensive Care Medicine, 1117 Public Health and Health Services, Special Article, 03 medical and health sciences, 0302 clinical medicine, Health care, Pandemic, medicine, Infection control, Critical illne, Grading (education), Intensive care medicine, Clinical practice guideline, business.industry, Conflict of interest, COVID-19, 1103 Clinical Sciences, 030208 emergency & critical care medicine, Emergency & Critical Care Medicine, Coronavirus, COVID-19 guideline, Systematic review, 030228 respiratory system, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Clinical practice guidelines, Critical illness, business
Abstract

Supplemental Digital Content is available in the text., Background: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. Methods: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. Results: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which four are best practice statements, nine are strong recommendations, and 35 are weak recommendations. No recommendation was provided for six questions. The topics were: 1) infection control, 2) laboratory diagnosis and specimens, 3) hemodynamic support, 4) ventilatory support, and 5) COVID-19 therapy. Conclusion: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new evidence in further releases of these guidelines.

Published
2020

29. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update

Author

Mark Crowther, Hannah Wunsch, Ryan Zarychanski, Massimo Antonelli, Daniel S. Chertow, Waleed Alhazzani, Muhammed Alshahrani, Greg S. Martin, Michelle N. Gong, Lennie P. G. Derde, Morten Hylander Møller, Frederick G. Hayden, Marlies Ostermann, Mitchell M. Levy, Wojciech Szczeklik, Younsuck Koh, Massimiliano Greco, Lisa Burry, Malgorzata M Bala, Naomi E Hammond, Simon Oczkowski, Andrew Rhodes, Bin Du, Ziad A. Memish, Laura Evans, Yaseen M. Arabi, Mark Loeb, Amy S. Arrington, Zainab Al Duhailib, Ruth M. Kleinpell, Craig M. Coopersmith, Kimberley Lewis, Lewis J. Kaplan, Amy L. Dzierba, Maurizio Cecconi, Eddy Fan, Leonard A. Mermel, Elizabeth Bridges, Giuseppe Citerio, Sheila Nainan Myatra, Flávia Ribeiro Machado, Allison McGeer, Jozef Kesecioglu, Fayez Alshamsi, Emilie P. Belley-Côté, Hallie C. Prescott, Manoj J. Mammen, Alhazzani, W, Evans, L, Alshamsi, F, Møller, M, Ostermann, M, Prescott, H, Arabi, Y, Loeb, M, Ng Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Machado, F, Wunsch, H, Crowther, M, Cecconi, M, Koh, Y, Burry, L, Chertow, D, Szczeklik, W, Belley-Cote, E, Greco, M, Bala, M, Zarychanski, R, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Nainan Myatra, S, Arrington, A, Kleinpell, R, Citerio, G, Lewis, K, Bridges, E, Memish, Z, Hammond, N, Hayden, F, Alshahrani, M, Al Duhailib, Z, Martin, G, Kaplan, L, Coopersmith, C, Antonelli, M, and Rhodes, A

Subjects
Adult, medicine.medical_specialty, Surviving Sepsis Campaign, Critical Care, Coronavirus Disease 2019 (COVID-19), Guideline, Critical Care and Intensive Care Medicine, medicine.disease_cause, Dexamethasone, Patient Positioning, 03 medical and health sciences, 0302 clinical medicine, Adrenal Cortex Hormones, Pandemic, medicine, Humans, Disease management (health), Intensive care medicine, COVID-19 Serotherapy, Coronavirus, Alanine, Evidence-Based Medicine, business.industry, Hemodynamics, Immunization, Passive, Anticoagulants, COVID-19, Disease Management, 030208 emergency & critical care medicine, Evidence-based medicine, Adenosine Monophosphate, Ventilation, Clinical trial, Intensive Care Units, Systematic review, 030228 respiratory system, Practice Guidelines as Topic, ICU, business, Hydroxychloroquine
Abstract

BACKGROUND: The coronavirus disease 2019 pandemic continues to affect millions worldwide. Given the rapidly growing evidence base, we implemented a living guideline model to provide guidance on the management of patients with severe or critical coronavirus disease 2019 in the ICU. METHODS: The Surviving Sepsis Campaign Coronavirus Disease 2019 panel has expanded to include 43 experts from 14 countries; all panel members completed an electronic conflict-of-interest disclosure form. In this update, the panel addressed nine questions relevant to managing severe or critical coronavirus disease 2019 in the ICU. We used the World Health Organization's definition of severe and critical coronavirus disease 2019. The systematic reviews team searched the literature for relevant evidence, aiming to identify systematic reviews and clinical trials. When appropriate, we performed a random-effects meta-analysis to summarize treatment effects. We assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach, then used the evidence-to-decision framework to generate recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. RESULTS: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued nine statements (three new and six updated) related to ICU patients with severe or critical coronavirus disease 2019. For severe or critical coronavirus disease 2019, the panel strongly recommends using systemic corticosteroids and venous thromboprophylaxis but strongly recommends against using hydroxychloroquine. In addition, the panel suggests using dexamethasone (compared with other corticosteroids) and suggests against using convalescent plasma and therapeutic anticoagulation outside clinical trials. The Surviving Sepsis Campaign Coronavirus Diease 2019 panel suggests using remdesivir in nonventilated patients with severe coronavirus disease 2019 and suggests against starting remdesivir in patients with critical coronavirus disease 2019 outside clinical trials. Because of insufficient evidence, the panel did not issue a recommendation on the use of awake prone positioning. CONCLUSION: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued several recommendations to guide healthcare professionals caring for adults with critical or severe coronavirus disease 2019 in the ICU. Based on a living guideline model the recommendations will be updated as new evidence becomes available.

Published
2021

30. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Author

Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, Cheng SH, Cheng CY, Chung WS, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang YW, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo CY, Le T, Lin YC, Lin WP, Lin TH, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O'Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng TY, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong HL, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Published
2024
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31. Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications.

Author

de Mul N, Verlaan D, Ruurda JP, van Grevenstein WMU, Hagendoorn J, de Borst GJ, Vriens MR, de Bree R, Zweemer RP, Vogely C, Haitsma Mulier JLG, Vernooij LM, Reitsma JB, de Zoete MR, Top J, Kluijtmans JAJ, Hoefer IE, Noordzij P, Rettig T, Marsman M, de Smet AMGA, Derde L, van Waes J, Rijsdijk M, Schellekens WJM, Bonten MJM, Slooter AJC, and Cremer OL

Subjects
Humans, Early Diagnosis, Longitudinal Studies, Postoperative Complications diagnosis, Postoperative Complications epidemiology, Biological Specimen Banks, Quality of Life
Abstract

Purpose: Although elective surgery is generally safe, some procedures remain associated with an increased risk of complications. Improved preoperative risk stratification and earlier recognition of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) cohort aims to establish a comprehensive biorepository that will facilitate research in this field. In this profile paper, we will discuss its design rationale and opportunities for future studies., Participants: Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first seven postoperative days, participants are subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel electroencephalography). Blood samples and microbiome specimens are collected at preselected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium/acute encephalopathy. Secondary outcomes include mortality and quality of life, as well as the long-term occurrence of psychopathology, cognitive dysfunction and chronic pain., Findings to Date: Enrolment of the first participant occurred early 2020. During the inception phase of the project (first 2 years), 431 patients were eligible of whom 297 patients consented to participate (69%). Observed event rate was 42% overall, with the most frequent complication being infection., Future Plans: The main purpose of the PLUTO biorepository is to provide a framework for research in the field of perioperative medicine and anaesthesiology, by storing high-quality clinical data and biomaterials for future studies. In addition, PLUTO aims to establish a logistical platform for conducting embedded clinical trials., Trial Registration Number: NCT05331118., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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32. ERS/ESICM/ESCMID/ALAT guidelines for the management of severe community-acquired pneumonia.

Author

Martin-Loeches I, Torres A, Nagavci B, Aliberti S, Antonelli M, Bassetti M, Bos L, Chalmers JD, Derde L, de Waele J, Garnacho-Montero J, Kollef M, Luna C, Menendez R, Niederman M, Ponomarev D, Restrepo M, Rigau D, Schultz MJ, Weiss E, Welte T, and Wunderink R

Subjects
Humans, Critical Care, Respiratory Care Units, Pneumonia diagnosis, Pneumonia therapy, Communicable Diseases
Abstract

Background: Severe community-acquired pneumonia (sCAP) is associated with high morbidity and mortality, and while European and non-European guidelines are available for community-acquired pneumonia, there are no specific guidelines for sCAP., Materials and Methodology: The European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Latin American Thoracic Association (ALAT) launched a task force to develop the first international guidelines for sCAP. The panel comprised a total of 18 European and four non-European experts, as well as two methodologists. Eight clinical questions for sCAP diagnosis and treatment were chosen to be addressed. Systematic literature searches were performed in several databases. Meta-analyses were performed for evidence synthesis, whenever possible. The quality of evidence was assessed with GRADE (Grading of Recommendations, Assessment, Development and Evaluation). Evidence to Decision frameworks were used to decide on the direction and strength of recommendations., Results: Recommendations issued were related to diagnosis, antibiotics, organ support, biomarkers and co-adjuvant therapy. After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention and implications to health equity, recommendations were made for or against specific treatment interventions., Conclusions: In these international guidelines, ERS, ESICM, ESCMID and ALAT provide evidence-based clinical practice recommendations for diagnosis, empirical treatment and antibiotic therapy for sCAP, following the GRADE approach. Furthermore, current knowledge gaps have been highlighted and recommendations for future research have been made., Competing Interests: Conflict of interest: I. Martin-Loeches reports grants from GE, consulting fees from Gilead and MSD, lecture honoraria from MSD, Gilead and Mundipharma, and advisory board and lectures for Pfizer, MSD and Menarini, outside the submitted work. A. Torres reports consulting fees and lecture honoraria from Pfizer, Poliphor, MSD, Jansen and OM Pharma, and advisory board and lectures for Pfizer, MSD, Atriva, Jansen and Menarini, outside the submitted work. B. Nagavci serves as the ERS methodologist. S. Aliberti reports grants from Insmed Incorporated, Chiesi, and Fisher & Paykel, royalties from McGraw Hill, consulting fees from Insmed Incorporated, Insmed Italy, Insmed Ireland Ltd, Zambon, AstraZeneca UK Limited, CSL Behring GmbH, Grifols, Fondazione Charta, Boehringer Ingelheim, Chiesi, Zcube Srl, Menarini and MSD Italia Srl, lecture honoraria from GlaxoSmithKline Spa, and advisory board participation with Insmed Incorporated, Insmed Italy, AstraZeneca UK Limited and MSD Italia Srl, outside the submitted work. M. Antonelli reports grants from GE, consulting fees from Gilead, lecture honoraria from MSD, Chiesi, Fisher & Pickel, and Orphan, and a leadership role at ESICM, outside the submitted work. M. Bassetti reports research grants and/or advisor/consultant and/or speaker/chairman for Bayer, Biomerieux, Cidara, Cipla, Gilead, Menarini, MSD, Pfizer, Shionogi and ThermoFisher, outside the submitted work. L. Bos reports grants from the Dutch Lung Foundation (young investigator grant), the Dutch Lung Foundation and Health Holland (public–private partnership grant), Dutch Lung Foundation (Dirkje Postma Award), IMI COVID19 initiative and Amsterdam UMC fellowship, outside the submitted work. J. Chalmers reports research grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences, Grifols, Novartis and Insmed, and received consultancy or speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Insmed, Janssen, Novartis, Pfizer and Zambon, outside the submitted work, and is chief editor of the ERJ. L. Derde reports grants from European Union's FP7 grant PREPARE (602525); EU FP7-HEALTH-2013-INNOVATION-1, grant number 602525, H2020 RECOVER grant agreement number 101003589, ZonMw grant ANAkinra voor de behandeling van CORonavirus infectious disease 2019 op de Intensive Care (ANACOR-IC) project number 10150062010003, lecture honoraria from Netherlands International Sepsis Symposium, travel support from ESICM, ISICEM, Weimar sepsis Update, European Respiratory Society, Critical Care Reviews, UPMC Pittsburgh, International Sepsis Forum and ANZICS/ACCCN ASM, and advisory board participation with Sepsis Canada International; REMAP-CAP has received drugs as part of the trial interventions; and the following leadership positions: chair, international trial steering committee, REMAP-CAP (2021–present), coordinating committee member, ECRAID (2021–present), member expert panel on COVID-19 therapeutics, European Commission (2021–present), member “Pandemic Preparedness Plan” committee, KNAW (2021–present), chair elect Education and Training Committee (2019–2021), chair Clinical Training Committee, ESICM (2019–2021), task force infectious threats, NVIC (chair 2019–2021), outside the submitted work. J. de Waele reports grants from Flanders Research Foundation and consulting fees from Pfizer and MSD, outside the submitted work. M. Kollef reports consulting fees from Merck, Pfizer and Shionogi, outside the submitted work. C. Luna reports grants as principal investigator in clinical trials, has participated on adjudication committee for diagnosis in clinical trials, has received honoraria for lectures on pulmonary infections, has received economical support for attending to the ERS and ATS meetings, and has participated on an advisory board for pneumococcal vaccines, outside the submitted work. R. Menendez reports lecture honoraria from, and participated on advisory boards for Pfizer, Advanz Pharma, Gilead Sciences and GSK, and travel support from Pfizer, Gilead and Advanz Pharma, outside the submitted work. M. Niederman reports grants from Shionogi, Merck and Bayer, consulting fees from Pfizer, Merck, Shionogi, Bayer, Nabriva and Thermo-Fisher, and participation on an advisory board for Fab'entec, outside the submitted work. D. Rigau formerly served as ERS methodologist. M. Schultz received grants from Zonmw (Netherlands Organisation For Health Research And Development) and financial support from Hamilton Medical AG, Switzerland, outside of this project. E. Weiss reports speaker and travel fees from MSD, Akcea Therapeutics and LFB, outside the submitted work. T. Welte reports grants from German Ministry of Research and Education, lecture honoraria from Advanz, Biotest, Thermo Fischer, MSD, Pfizer and Shionogi, outside the submitted work. R. Wunderink reports consultancy and lectures for bioMerieux, and consultancy for MSD, Shionogi, LaJolla, Venatorx, Vir and Microbiotx, and has acted as chairman, clinical evaluation committee for Pfizer, and as DSMB member for Vir, outside the submitted work. All other authors have nothing to disclose., (The content of this work is not subject to copyright. Design and branding are copyright ©ERS 2023. For reproduction rights and permissions contact permissions@ersnet.org.)

Published
2023
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33. A guide to immunotherapy for COVID-19.

Author

van de Veerdonk FL, Giamarellos-Bourboulis E, Pickkers P, Derde L, Leavis H, van Crevel R, Engel JJ, Wiersinga WJ, Vlaar APJ, Shankar-Hari M, van der Poll T, Bonten M, Angus DC, van der Meer JWM, and Netea MG

Subjects
Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Neutralizing therapeutic use, Azetidines therapeutic use, Bradykinin analogs & derivatives, Bradykinin therapeutic use, Bradykinin B2 Receptor Antagonists therapeutic use, COVID-19 immunology, Dexamethasone therapeutic use, Drug Combinations, Factor Xa Inhibitors therapeutic use, Heparin therapeutic use, Humans, Hydrocortisone therapeutic use, Imatinib Mesylate therapeutic use, Immunization, Passive, Interferon beta-1a therapeutic use, Interferon beta-1b therapeutic use, Interferon-gamma therapeutic use, Interleukin 1 Receptor Antagonist Protein therapeutic use, Kallikrein-Kinin System, Piperidines therapeutic use, Purines therapeutic use, Pyrazoles therapeutic use, Pyrimidines therapeutic use, SARS-CoV-2, Sulfonamides therapeutic use, COVID-19 Serotherapy, Anticoagulants therapeutic use, COVID-19 therapy, Complement Inactivating Agents therapeutic use, Glucocorticoids therapeutic use, Immunologic Factors therapeutic use, Immunomodulation, Protein Kinase Inhibitors therapeutic use
Abstract

Immune dysregulation is an important component of the pathophysiology of COVID-19. A large body of literature has reported the effect of immune-based therapies in patients with COVID-19, with some remarkable successes such as the use of steroids or anti-cytokine therapies. However, challenges in clinical decision-making arise from the complexity of the disease phenotypes and patient heterogeneity, as well as the variable quality of evidence from immunotherapy studies. This Review aims to support clinical decision-making by providing an overview of the evidence generated by major clinical trials of host-directed therapy. We discuss patient stratification and propose an algorithm to guide the use of immunotherapy strategies in the clinic. This will not only help guide treatment decisions, but may also help to design future trials that investigate immunotherapy in other severe infections., (© 2022. Springer Nature America, Inc.)

Published
2022
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34. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Author

Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, Cheng SH, Cheng CY, Chung WS, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang YW, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo CY, Le T, Lin YC, Lin WP, Lin TH, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O'Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng TY, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong HL, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Published
2021
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35. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Author

Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, Cheng SH, Cheng CY, Chung WS, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang YW, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo CY, Le T, Lin YC, Lin WP, Lin TH, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O'Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng TY, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong HL, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Subjects
Adult, COVID-19 complications, COVID-19 virology, Child, Chloroquine administration & dosage, Combined Modality Therapy adverse effects, Combined Modality Therapy methods, Comorbidity, Female, Humans, Hydroxychloroquine administration & dosage, International Cooperation, Odds Ratio, Patient Participation statistics & numerical data, Pregnancy, Pregnancy Complications, Infectious drug therapy, Pregnancy Complications, Infectious virology, Randomized Controlled Trials as Topic statistics & numerical data, SARS-CoV-2, COVID-19 mortality, Chloroquine adverse effects, Hydroxychloroquine adverse effects, Pregnancy Complications, Infectious mortality, COVID-19 Drug Treatment
Abstract

Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.

Published
2021
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36. Sudden cardiac arrest as a presentation of Brugada syndrome unmasked by thyroid storm.

Author

Korte AK, Derde L, van Wijk J, and Tjan DH

Subjects
Adolescent, Brugada Syndrome diagnosis, Brugada Syndrome physiopathology, Electrocardiography, Humans, Male, Brugada Syndrome complications, Death, Sudden, Cardiac etiology, Graves Disease complications, Thyroid Crisis etiology
Abstract

An 18-year-old man suffered a sudden cardiac arrest with ventricular fibrillation and was successfully resuscitated. He had neither a medical nor family history of cardiac disease/sudden death, but was known to have Graves' disease, for which he was treated with radioactive iodine. Recently, block-and-replacement therapy had been discontinued to evaluate thyroid functioning. On admission, thyroid hormone levels were markedly elevated, suggesting thyroid storm due to residual Graves' disease. The patient was treated with propylthiouracil, hydrocortisone and Lugol solution. ECG showed repolarisation patterns suggestive of an underlying type 1 Brugada syndrome (BS). These findings were confirmed by an additional ajmaline test. An implantable cardioverter defibrillator was implanted to prevent future arrhythmias. The patient underwent total thyroidectomy 9 months later and recovered completely. To the best of our knowledge, this is the first reported case of a sudden cardiac arrest as a presentation of BS unmasked by thyroid storm., (2015 BMJ Publishing Group Ltd.)

Published
2015
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37. KPC-Like Carbapenemase-Producing Enterobacteriaceae Colonizing Patients in Europe and Israel.

Author

Baraniak A, Izdebski R, Fiett J, Herda M, Derde LP, Bonten MJ, Adler A, Carmeli Y, Goossens H, Hryniewicz W, Brun-Buisson C, and Gniadkowski M

Subjects
Citrobacter freundii drug effects, Citrobacter freundii genetics, Citrobacter freundii isolation & purification, DNA Transposable Elements genetics, Enterobacteriaceae Infections microbiology, Escherichia coli drug effects, Escherichia coli genetics, Escherichia coli isolation & purification, Europe, Humans, Israel, Klebsiella pneumoniae genetics, Klebsiella pneumoniae isolation & purification, Plasmids genetics, Anti-Bacterial Agents therapeutic use, Bacterial Proteins biosynthesis, Bacterial Proteins genetics, Carbapenems therapeutic use, Enterobacteriaceae Infections drug therapy, Klebsiella pneumoniae drug effects, beta-Lactamases biosynthesis, beta-Lactamases genetics
Abstract

In a 2008-2011 survey, 17,945 patients in 18 hospital units in Europe and Israel were screened for carriage of Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae, resulting in identification of 124 positive patients. The isolates were dominated by Klebsiella pneumoniae sequence type 258 (ST258) KPC-2 and ST512 KPC-3, mainly from Greece and Italy, respectively, whereas Israeli isolates were of diverse species, clones, and KPC variants. Various blaKPC platforms were observed, among which IncFIIK-FIBK plasmids with blaKPC-2/-3 genes in the Tn4401a transposon prevailed., (Copyright © 2016, American Society for Microbiology. All Rights Reserved.)

Published
2015
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