5. PRACTICE C: Randomized, embedded, multifactorial, adaptive platform trial severe CAP –workpackage 5

European adaptive randomised controlled trial to improve survival in ICU-admitted patients with Severe Community Acquired Pneumonia (sCAP).

REMAP-CAP: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia

This is a perpetual European adaptive RCT evaluating the effectiveness of several interventions in increasing the number of ventilator and vasopressor free days(day-60) and reducing day-60 mortality in adult patients admitted to ICU with sCAP. We will use CAP as disease definition, because the patients with disease represent most of morbidity and mortality caused by SARI in the developed world. Each intervention will be compared to standard care using a Bayesian approach for statistical analysis. The study will be performed in adult intensive care units (ICU) and will have 2,000-4,000 patients enrolled in 100 – 150 ICU across Europe. The targeted patient population are adults, highly suspected of CAP (at least two clinical signs and symptoms and radiological confirmation), requiring invasive mechanical ventilation within the first 48h after presentation to the hospital and are subsequently admitted to ICU.

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Key Objectives

This study aims to:

  1. inform evidence-based guidelines for optimal ICU management of patients with sCAP, before and during EID outbreaks;
  2. select the most suitable interventions for evaluation in adult patients with sCAP admitted to ICU;
  3. finalise the design of a perpetual European adaptive RCT to improve survival in patients with sCAP suited to rapidly adapt interventions and clinical syndromes (i.e. non-sCAP) at the time of epidemics;
  4. determine the effectiveness of different interventions in critically ill adult patients with sCAP in reducing day-60 mortality when compared to standard care;
  5. determine the effectiveness of different interventions in critically ill adult patients with sCAP in reducing, when compared to standard care, hospital mortality, ICU length of stay, hospital length of stay, 30-day and 60-day organ failure free days and ventilation free days.

Team members

Marc Bonten Coordinator
Alistair Nichol Coordinating team
Steve Webb Team member
Derek Angus Team member
Lennie Derde Team member
Gernot Rohde Chairman Executive Board CAPNETZ Stiftung
Wilma van Bentum-Puijk Project Manager
Sebastiaan Hullegie Junior Project Manager
Colin McArthur Team member
Scott Berry Team member
Anthony Gordon Team member
Frank Brunkhorst Team member
Kathy Rowan Team member

Contact us

Coordinator:

Herman Goossens

Herman.Goossens@uza.be

Deputy Coordinator:

Menno de Jong

m.d.dejong@amc.uva.nl

prepare@uantwerpen.be

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