About: The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design

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About: The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design
Creator	Murthy, Srinivas Goossens, Herman Bonten, Marc Arabi, Yaseen Rohde, Gernot De Jong, Menno Cheng, Allen Kruger, Peter Lamontagne, Francois Chiche, Jean-Daniel Gordon, Anthony Marshall, John Nichol, Alistair Angus, Derek John, St Parke, Rachael Young, Paul Webb, Steven Al-Beidh, Farah Berry, Scott Bhimani, Zahra Broglio, Kristine Brunkhorst, Frank Derde, Lennie Detry, Michelle Green, Cameron Higgins, Alisa Hullegie, Sebastiaan Lewis, Roger Litton, Edward Mcarthur, Colin Mcguinness, Shay Mcglothlin, Anna Mouncey, Paul O'neill, Genevieve Parker, Jane Rowan, Kathryn Turner, Anne Van Bentum-Puijk, Wilma
Source	Medline; PMC
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. 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).
has issue date	2020-07-01(xsd:dateTime)
bibo:doi	10.1513/annalsats.202003-192sd
bibo:pmid	32267771
has license	cc-by-nc-nd
sha1sum (hex)	d867f36b1b3816d001ec0471d63e2ce0863db011
schema:url	https://doi.org/10.1513/annalsats.202003-192sd
resource representing a document's title	The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design
has PubMed Central identifier	PMC7328186
has PubMed identifier	32267771
schema:publication	Ann Am Thorac Soc
resource representing a document's body	covid:d867f36b1b3816d001ec0471d63e2ce0863db011#body_text
is schema:about of	named entity 'REMAP' named entity 'CLINICAL STUDY DESIGN' named entity 'IFN' named entity 'corticosteroids' named entity 'March 2020' named entity 'Human subject' named entity 'ICU' named entity 'tidal volume' named entity 'CAP' named entity 'healthcare-associated pneumonia' named entity 'CAP' named entity 'Safety Monitoring' named entity 'intubated' named entity 'CAP' named entity 'influenza infection' named entity 'prior probabilities' named entity 'RAR' named entity 'probability' named entity 'EHR' named entity 'oxygen' named entity 'ICU' named entity 'type 1 and type 2 errors' named entity 'antibiotics' named entity 'acute myocardial infarction' named entity 'RCT' named entity 'infection' named entity 'CAP' named entity 'antiviral therapy' named entity 'probability' named entity 'Community-acquired Pneumonia' named entity 'ICU' named entity 'CAP' named entity 'clavulanate' named entity 'CAP' named entity 'CAP' named entity 'critical care' named entity 'ad infinitum' named entity 'CAP' named entity 'probability' named entity 'lung' named entity 'probability' named entity 'adaptive designs' named entity 'immune modulation'

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