A RESPONSIVE ADAPTIVE TRIAL BATTLING THE PANDEMIC
THE REMAP-CAP TRIAL
Severe Community Acquired Pneumonia (severe CAP) is a major cause of mortality. The REMAP-CAP Trial is a multi-centre randomised controlled platform trial utilising Bayesian adaptive methods for ICU patients with severe CAP to be analysed in conjunction with patients enrolled with COVID-19.
LATEST REPORT
Primary Outcome: Day 90 mortality for pneumonia patients.
Day 21 Ventilater free days for Covid-19 patients
CASE STUDY
“Spiral has been an amazing partner in solving many of the challenges that arose with this trial”
STEVE WEBB, REMAP-CAP TRIAL
REMAP-CAP DOMAINS
REMAP-CAP is flexible, meaning there are multiple domains and interventions that all participating sites are able to choose from. REMAP-CAP currently has 11 active domains. Additional interventions against COVID-19 are being considered and may be introduced into these domains. Current protocol documents for COVID-19 domains can be found here.
REMAP-CAP is also exploring options to increase the number of participating sites in current locations, as well as commencing recruitment in new countries.
Click on the images below to explore these domains and the results they are having in the fight against Covid-19.
BACKGROUND
Community-acquired pneumonia (CAP), that is of sufficient severity to require admission to an Intensive Care Unit (ICU), is associated with substantial mortality.
In Australia, CAP is responsible for more than 7000 ICU admissions and 1400 deaths each year. The annual direct cost of ICU care of these patients is in the order of $200 million.
All patients with severe pneumonia who are treated in an ICU will receive therapy that consists of a combination of multiple different treatments.
TRIAL DESIGN
The study will enrol adult patients with severe CAP who are admitted to ICUs using a design known as a REMAP, which is a type of platform trial.
Eligible participants will be randomised to receive one intervention in each of one or more domains.
Bayesian statistical methods will be used to establish the superiority, inferiority, or equivalence of interventions within a domain. Interventions determined to be superior will be incorporated into standard care within the ongoing REMAP. Interventions determined to be inferior will be discontinued.
This REMAP uses an adaptive design, relying on pre-specified criteria for adaptation.
KEY CONNECTIONS
Global Project Manager, Cameron Green. Project Manager, The ANZIC Research Centre, Monash University.
Executive Director Australia and New Zealand, Professor Steve Webb, ANZ Executive Director. Senior Staff Specialist, Intensive Care Medicine, Royal Perth Hospital. Clinical Professor, School of Medicine and Pharmacology and the School of Population Health, University of Western Australia. Clinical Professor, School of Public Health and Preventive Medicine, Monash University. Foundation Member of the REMAP-CAP Family.
European Coordinating Investigator, Lennie Derde. Associate Professor, UMC Utrecht.
Funding
Canadian Institutes of Health Research
PREPARE, EU
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Our Spiral Project Lead and EDC Platform manager for the REMAP-CAP trial is Jess Wren.
In charge of overseeing software development that’s used in clinical trials, Jess not only engages clients but, like glue, she also pulls the team together along the path of delivery.
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“You hear of working in an agile environment but this really is as agile as it gets.”