The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design
| العنوان: | The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design |
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| المؤلفون: | Jean Daniel Chiche, Alistair Nichol, Allen C. Cheng, Zahra Bhimani, Peter Kruger, Genevieve K. O'Neill, Paul J Young, Anthony C. Gordon, Jane Parker, Rachael Parke, Derek C. Angus, Kathryn M Rowan, Sebastiaan J. Hullegie, Anne Turner, Anna McGlothlin, Paul R Mouncey, Roger J. Lewis, John Marshall, Farah Al-Beidh, Steven A R Webb, Kristine Broglio, Srinivas Murthy, Lennie P. G. Derde, Colin McArthur, Alisa Higgins, Edward Litton, Scott M. Berry, Yaseen M. Arabi, Gernot Rohde, Menno de Jong, Herman Goossens, Frank M. Brunkhorst, Marc J.M. Bonten, Cameron Green, Wilma van Bentum-Puijk, Shay McGuinness, Michelle A. Detry, Francois Lamontagne |
| المساهمون: | AII - Infectious diseases, Medical Microbiology and Infection Prevention |
| المصدر: | Annals of the American Thoracic Society Annals of the American Thoracic Society, vol 17, iss 7 Proceedings of the American Thoracic Society Annals of the American Thoracic Society, 17(7), 879-891. American Thoracic Society |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | community-acquired pneumonia, Respiratory System, Psychological intervention, Disease, law.invention, 0302 clinical medicine, Community-acquired pneumonia, Randomized controlled trial, law, Bayesian adaptive platform trial, Medicine, 030212 general & internal medicine, Viral, Clinical Study Design, Evidence-Based Medicine, Coronavirus disease 2019, master protocol, Bayesian adaptive, Intensive care unit, 3. Good health, Anti-Bacterial Agents, Community-Acquired Infections, Randomized clinical trial, Coronavirus Infections, Human, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Randomization, Point-of-Care Systems, Clinical Sciences, Pneumonia, Viral, Antiviral Agents, 03 medical and health sciences, coronavirus disease 2019, Betacoronavirus, Intensive care, Influenza, Human, Master protocol, Humans, Intensive care medicine, Pandemics, business.industry, SARS-CoV-2, COVID-19, Evidence-based medicine, Pneumonia, medicine.disease, randomized clinical trial, Influenza, 030228 respiratory system, platform trial, Human medicine, business |
| الوصف: | 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. The trial uses a novel design, entitled “a randomized embedded multifactorial adaptive platform.” The design has five key features: 1) randomization, allowing robust causal inference; 2) embedding of study procedures into routine care processes, facilitating enrollment, trial efficiency, and generalizability; 3) a multifactorial statistical model comparing multiple interventions across multiple patient subgroups; 4) response-adaptive randomization with preferential assignment to those interventions that appear most favorable; and 5) a platform structured to permit continuous, potentially perpetual enrollment beyond the evaluation of the initial treatments. The trial randomizes patients to multiple interventions within four 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 (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) was approved and enrolling patients in 52 intensive care units in 13 countries on 3 continents. In February, it transitioned into pandemic mode with several design adaptations for coronavirus disease 2019. 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 www.clinicaltrials.gov (NCT02735707). |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2325-6621 1546-3222 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c8e6034412888a3fc7b082650d30eb1b https://doi.org/10.1513/annalsats.202003-192sd |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....c8e6034412888a3fc7b082650d30eb1b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23256621 15463222 |
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