Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.
The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.
In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.
REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.
Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality.
Patients with pneumonia who are being treated in an ICU will receive therapy that consists of 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 clinical 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:
It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission.
Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.
REMAP-CAP PLATFORM INCLUSION CRITERIA:
Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:
Up to 48 hours after ICU admission, receiving organ support with one or more of:
PLATFORM EXCLUSION CRITERIA:
Healthcare-associated pneumonia:
Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
Previous participation in this REMAP within the last 90 days
REMAP-COVID PLATFORM INCLUSION CRITERIA
1. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection.
REMAP-COVID PLATFORM EXCLUSION CRITERIA
DOMAIN-SPECIFIC ELIGIBLE CRITERIA:
Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org).
info@remapcap.org
EU.remapcap@umcutrecht.nl
Providence, Rhode Island 02903, United States
Saint Catharines, Ontario L2S 0A9, Canada
Palermo, 90127, Italy
Bucharest, 030303, Romania
Nottingham, England NG7 2UH, United Kingdom
Royal Tunbridge Wells, England TN2 4QJ, United Kingdom
Wolverhampton, England WV10 0QP, United Kingdom
Cardiff, Wales CF14 4XW, United Kingdom
Haywards Heath, RH16 4EX, United Kingdom
Newcastle upon Tyne, NE1 4LP, United Kingdom