ANZICS CTG Supported Study
Randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia
Severe Community Acquired Pneumonia (severe CAP) is a major cause of 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. The existing evidence-base, for treatment of patients with severe CAP is limited, reflected in variation in Australian and international guidelines as well as variation in practices including choice of antibiotic, choice of ventilator strategy, and use of immune-modulating agents. Accordingly, we have designed a multi-centre randomised controlled platform trial utilising Bayesian adaptive methods for Australian and New Zealand ICU patients with severe CAP to be analysed in conjunction with patients enrolled in other locations, making it the largest study on severe CAP ever conducted.
In addition, REMAP-CAP was designed to provide Australia and New Zealand with a pre-prepared global research response to pandemics of Severe Acute Respiratory Illness (SARI). During the COVID-19 pandemic, REMAP-CAP platform has seamlessly and rapidly (within days) adapted to evaluate the most promising interventions for pandemic infection and rapidly and efficiently provide high-quality research evidence to guide clinical practice during the pandemic.
The inter-pandemic primary outcome measure is 90-day all-cause mortality. The pandemic primary outcome measure is a hierarchical ordinal scale of days spent alive and not receiving ICU organ failure support to 21 days post-randomisation. Other outcome measures include the development and resolution of organ failure; domain-specific endpoints; ICU and hospital length of stay; and post-hospital outcomes including Health Related Quality of life using the EQ5D and disability status using the WHO-DAS assessed at 6 months. This landmark perpetual trial will provide evidence to change clinical practice in Australia and worldwide. This trial has also introduced adaptive platform trials to the Australian and international research community.
Shay McGuinness (Chair), Yaseen Arabi, Besa Beqai, Aidan Burrell, Lewis Campbell, Allen Cheng, Lennie Derde, Andrew Forbes, David Gattas, Cameron Green (Global Project Manager), Stephane Heritier, Tom Hills, Peter Kruger, Colin McArthur, Bec McEldrew, Zoe McQuilten, Susan Morpeth, Alistair Nichol, Rachael Parke, Jane Parker (Australian Project Manager), Sandra Peake, Jeff Presneill, Claire Reynolds, Manoj Saxena, Ian Seppelt, Vanessa Singh, Tony Trapani, Anne Turner (New Zealand Project Manager), Steve Webb and Paul Young comprise the ANZ Regional Management Committee. There are also additional international committees for each domain of the Platform (with ANZ members) and a European Regional Management Committee (with ANZ members).
NHMRC, Minderoo Foundation, MRFF,
Steve Webb (email)