Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02735707
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2015-12-11
Brief Title:
Randomized Embedded Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Randomized Embedded Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMAP-CAP
Brief 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
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
Detailed 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 dont 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 arent 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
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 dont 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 arent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 158584 | OTHER_GRANT | Canadian Institute of Health Research | None |
| 2015-002340-14 | EUDRACT_NUMBER | None | None |
| 602525 | OTHER_GRANT | None | None |
| 16631 | OTHER_GRANT | None | None |
| APP1101719 | OTHER_GRANT | None | None |
| 2023-507889-89-00 | CTIS | None | None |
| 965313 | OTHER_GRANT | None | None |