ANZICS CTG Supported Study

REMAP-CAP

Randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia

Study Description

Patients with pneumonia (infection of the lungs) who are being treated in an intensive care unit (ICU) will receive many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don’t always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.

This study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren’t able to do that.

REMAP-CAP has been designed to:

Test several treatments, at the same time, in the same patient.
Look at the results as it goes and uses these results so that new patients in the study have a better chance of getting better treatments
Drop treatments if they are shown to be less effective than others
Add new treatments to the study as those that have undergone testing complete their evaluation

The primary objective is to determine the impact on 90 day mortality of:

Alternative antibacterial strategies
Administration of azithromycin, acting as an immunomodulatory agent
Administration of a Corticosteroid
Administration of an antiviral agent
Activate different interventions during a pandemic &
Evaluate additional interventions over the life-time of the platform (e.g. different ventilation strategies)

Management Committee

ANZ Regional Management Committee: Shay McGuinness (Chair), Allen Cheng, Lennie Derde, Andrew Forbes, David Gattas, Cameron Green (Global Project Manager), Stephane Heritier, Lisa Higgins, Peter Kruger, Ed Litton, Colin McArthur, Alistair Nichol, Rachael Parke, Jane Parker (Australian Project Manager), Jeff Presneill, Tony Trapani, Anne Turner (New Zealand Project Manager), Steve Webb and Paul Young.

International Trial Steering Committee: Steve Webb (Chair), Derek Angus, Scott Berry, Zahra Bhimani, Marc Bonten, Frank Brunkhorst, Allen Cheng, Menno De Jong, Lennie Derde, Herman Goossens, Anthony Gordon, Cameron Green (Global Project Manager), Roger Lewis, Ed Litton, John Marshall, Colin McArthur, Shay McGuinness, Srinivas Murthy, Alistair Nichol, Rachael Parke, Jane Parker (Australian Project Manager), Kathy Rowan, Anne Turner (New Zealand Project Manager) and Wilma van Bentum-Puijk.

There are also additional international committees for each domain of the Platform (with ANZ members) and a European Regional Management Committee (with ANZ members).

Administering Institution

ANZIC Research Centre, Monash University
Medical Research Institute of New Zealand.

Collaborators

PREPARE
Berry Consulting LLC
ISARIC
ASID CRN
Julius Center at the University Medical Center Utrecht
APPRISE Center for Research Excellence
Canadian Critical Care Trials Group

Sample Size

6800 patients

Funding

NHMRC – Project Grant – $4,413,145.20
HRC NZ – Programme Grant – NZ$4,800,000
European Union FP7-HEALTH-2013-INNOVATION (2013 – onwards)
Canadian Institutes of Health Research Government- Strategy for Patient-Oriented Research funding (2018 onwards) Minderoo Foundation (2020 onwards) Health Research Board of Ireland (2020 onwards) UK National Institute for Health Research (NIHR) (2020 onwards) The UPMC Learning While Doing Program (2020 onwards) The Breast Cancer Research Foundation (2020 onwards) The French Ministry of Health (2020 onwards) NSW Health (2021)

Project Status

Since the beginning of the COVID-19 pandemic, REMAP-CAP has expanded significantly to evaluate therapies for this disease.

The number of sites participating in this trial has increased from 50 sites in 12 countries to more than 300 sites in 15 countries. The number of domains has increased from four to 14, with a number of additional domains under construction.

Available domains include:

Antibiotic Domain
Macrolide Duration Domain
Corticosteroid Domain
Influenza Antiviral Domain
COVID-19 Antiviral Domain
COVID-19 Immune Modulation Domain
COVID-19 Immunoglobulin Domain
Therapeutic Anticoagulation Domain
Vitamin C Domain
Simvastatin Domain
Antiplatelet Therapy Domain
Mechanical Ventilation Strategy Domain
ACE2 RAAS Domain
COVID-19 Immune Modulation 2 Domain
Ventilation Domain In addition, the REMAP-CAP platform has adapted to allow for the inclusion of patients in a ‘moderate’ disease state (i.e. those patients who do not require organ support in an ICU).

Reference

CTG1415-02
NCT02735707

Contact

Steve Webb (email)
https://www.remapcap.org

Publications

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 JD, 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. The Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia (REMAP-CAP) Study: Rationale and Design. Ann Am Thorac Soc. 2020 Apr 8. doi: 10.1513/AnnalsATS.202003-192SD. [Epub ahead of print] PubMed PMID: 32267771.
https://www.atsjournals.org/doi/10.1513/AnnalsATS.202003-192SD