Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

  • End date
    Dec 27, 2025
  • participants needed
  • sponsor
    UMC Utrecht
Updated on 28 December 2021


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:

  • 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.

Condition Community-acquired Pneumonia, Influenza, COVID-19
Treatment Clopidogrel, Lopinavir/Ritonavir, prasugrel, Placebo, Aspirin, Tocilizumab, Anakinra, Vitamin C, Amoxicillin-clavulanate, Apremilast, Hydrocortisone, Simvastatin, Cysteamine, ceftriaxone, hydroxychloroquine, Ticagrelor, ECCO2R, Ceftaroline, Interferon beta-1a, P2Y12 inhibitor, Amoxicillin Clavulanate, Piperacillin-tazobactam, Antibiotic A, Antibiotic B, Minimal distension, Maximal recruitment, Ivermectin, Piperacillin tazobactam, Sarilumab, Moxifloxacin or Levofloxacin, Macrolide administered for 3 days, Macrolide administered for up to 14 days, Fixed-duration Hydrocortisone, Shock-dependent hydrocortisone, Macrolide administered for 3-5 days, Five-days oseltamivir, Ten-days oseltamivir, Hydroxychloroquine + lopinavir/ritonavir, Convalescent plasma, Angiotensin converting enzyme inhibitor, Interferon-β1a, Fixed-duration higher dose Hydrocortisone, Therapeutic Anticoagulation, Intermediate dose thromboprophylaxis, Angiotensin Receptor Blockers, Protocolised mechanical ventilation strategy, Lopinavir / Ritonavir, Eritoran, Standard course macrolide, Extended course macrolide, No systemic corticosteroid, No antiviral agent for influenza, No antiviral agent for COVID-19, No immune modulation for COVID-19, Local standard venous thromboprophylaxis, Conventional low dose thromboprophylaxis, Continuation of therapeutic dose anticoagulation, No immunoglobulin, Delayed administration of convalescent plasma, No vitamin C, No antiplatelet, No simvastatin, Clinician-preferred mechanical ventilation strategy, No renin-angiotensin system inhibitor, ARB + DMX-200, No cysteamine
Clinical Study IdentifierNCT02735707
SponsorUMC Utrecht
Last Modified on28 December 2021


Yes No Not Sure

Inclusion Criteria

Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission
symptoms or signs or both that are consistent with lower respiratory tract infection AND
Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
Up to 48 hours after ICU admission, receiving organ support with one or more of
Non-invasive or Invasive ventilatory support
Receiving infusion of vasopressor or inotropes or both

Exclusion Criteria

Healthcare-associated pneumonia
Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
Resident of a nursing home or long term care facility
Death is deemed to be imminent and inevitable during the next 24 hours AND one or more
Previous participation in this REMAP within the last 90 days
of the patient, substitute decision maker or attending physician are not
committed to full active treatment
Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection
Patient is expected to be discharged from hospital today or tomorrow
More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection
Previous participation in this REMAP within the last 90 days
Each domain may have additional eligibility criteria. Refer to the study website for more
information ([www.remapcap.org](http://www.remapcap.org/))
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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