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 on:

  1. Alternative antibacterial strategies
  2. Administration of azithromycin, acting as an immunomodulatory agent
  3. Administration of a Corticosteroid
  4. Activate different interventions during a pandemic &
  5. Following on from these 3 initial research questions to evaluate additional interventions over the life-time of the platform (e.g. different ventilation strategies)

Management Committee

Steve Webb (Chair), Alistair Nichol, Allen Cheng, Andrew Forbes, Anne Turner (Project Manager – New Zealand), Colin McArthur, Ed Litton, Genevieve O’Neill (Project Manager – Australia), Jeff Presneill, Lisa Higgins, Jane Parker, Lynnette Murray, Lennie Derde, Paul Young, Rachael Parke, Shay McGuinness, Stephane Heritier, David Gattas, and Peter Kruger 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).

Administering Institution

ANZIC-Research Centre and MRINZ

Collaborators

PREPARE
Berry Consulting LLC
ISARIC
ASID CRN
Julius Center at the University Medical Center Utrecht
APPRISE Center for Research Excellence

Sample Size

6800 patients

Funding

NHMRC  – Project Grant – $4,413,145.20
HRCNZ – Programme Grant – $4,800,000 (NZD)
European Union FP7-HEALTH-2013-INNOVATION (2013 – onwards)

Project Status as of June 2018

REMAP-CAP has ethics approvals at hospitals across Australia and New Zealand (ANZ).

Auckland City Hospital Department of Critical Care Medicine in New Zealand has commenced recruitment. Hospitals across ANZ will commence recruitment 2018 winter and summer.

Current active Domain:

  • Antibiotic Domain
  • Macrolide Duration Domain

Corticosteroid Domain (pending updated protocol incorporating the ADRENAL study findings).

Reference

CTG ID No CTG 1415-02
NCT02735707

Contact

Steve Webb (email)