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:
- Evaluate multiple treatment strategies, at the same time, in the same patient.
- Reach platform conclusions when sufficient data is accrued, rather than when a
pre-specified sample size is reached
- Utilise data that is already accrued to increase the likelihood that patients within
the trial are randomised to treatments that are more likely to be beneficial
- New questions can be substituted into the trial as initial questions are answered,
meaning that the trial can be perpetual or open-ended
- Interactions between interventions in different domains can be evaluated
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.
