Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
-
- STATUS
- Recruiting
-
- End date
- Dec 27, 2025
-
- participants needed
- 10000
-
- sponsor
- UMC Utrecht
Summary
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.
Description
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.
Details
| 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 Identifier | NCT02735707 |
| Sponsor | UMC Utrecht |
| Last Modified on | 28 December 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer