NCT02735707 Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
| NCT ID | NCT02735707 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | UMC Utrecht |
| Condition | Respiratory Tract Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2016-04-11 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 20,000 participants in total. It began in 2016-04-11 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 hospitalised patients admitted to intensive care with respiratory tract infections. 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.
Eligibility Criteria
The eligibility criteria for the Platform are applied at multiple levels. One level is that there are inclusion and exclusion criteria that determine eligibility for randomization within the Platform. Another level is that, once eligible for inclusion within the Platform, additional criteria (typically exclusion criteria) are applied that are specific to each domain. Finally, intervention-level eligibility criteria may be applied for interventions within a domain. A patient is eligible for inclusion within a domain when: * All Platform inclusion criteria are met * None of the Platform exclusion criteria are met * Domain-specific eligibility criteria are met * The patient is eligible for at least two interventions within a domain As such, the key "inclusion criteria" for being eligible for a domain are that the patient is eligible for the Platform. \-- PLATFORM INCLUSION CRITERIA: 1. Hospitalised patient 2. Acute respiratory tract infection 3. Aged 28 days or older PLATFORM EXCLUSION CRITERIA: 1. 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 2. Patient is expected to be discharged from hospital within the next 24 hours 3. Previous participation in this REMAP within the last 90 days DOMAIN-SPECIFIC ELIGIBILITY CRITERIA: Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org).
Contact & Investigator
Cameron Green, MSc
✉ info@remapcap.orgSteve Webb, Prof
STUDY CHAIR
Monash University, Study Chair REMAP-CAP Australia
Frequently Asked Questions
Who can join the NCT02735707 clinical trial?
This trial is open to participants of all sexes, aged 28 Days or older, studying Respiratory Tract Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02735707 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 20,000 participants.
Is NCT02735707 currently recruiting?
Yes, NCT02735707 is actively recruiting participants. Contact the research team at info@remapcap.org for enrollment information.
Where is the NCT02735707 trial being conducted?
This trial is being conducted at Jacksonville, United States, Augusta, United States, Chicago, United States, New Orleans, United States and 11 additional locations.
Who is sponsoring the NCT02735707 clinical trial?
NCT02735707 is sponsored by UMC Utrecht. The principal investigator is Steve Webb, Prof at Monash University, Study Chair REMAP-CAP Australia. The trial plans to enroll 20,000 participants.