RECRUITING

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

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Conditions

Community-acquired Pneumonia, Influenza, COVID-19PneumoniaLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsAnti-Bacterial AgentsMoxifloxacinLevofloxacinAntibioticsHydrocortisoneAnti-Infective AgentsCeftriaxonePiperacillin-tazobactamCeftarolineAmoxicillin-clavulanateOseltamivirCOVID-19InfluenzaIntensive careCritical careSARS-CoV-2Vitamin CTherapeutic AnticoagulationStatinInvasive Mechanical VentilationConvalescent plasmaEritoranApremilastDMX-200IvermectinBaloxavirTocilizumabBaricitinibImatinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-04-11
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02735707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:
  2. 1. symptoms or signs or both that are consistent with lower respiratory tract infection AND
  3. 2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
  4. 2. Up to 48 hours after ICU admission, receiving organ support with one or more of:
  5. 1. Non-invasive or Invasive ventilatory support;
  6. 2. Receiving infusion of vasopressor or inotropes or both
  1. 1. Healthcare-associated pneumonia:
  2. 1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
  3. 2. Resident of a nursing home or long term care facility
  4. 2. 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
  5. 3. Previous participation in this REMAP within the last 90 days
  6. 1. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection.
  7. 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
  8. 2. Patient is expected to be discharged from hospital today or tomorrow
  9. 3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection.
  10. 4. Previous participation in this REMAP within the last 90 days

Contacts and Locations

Study Contact

Cameron Green, MSc
CONTACT
info@remapcap.org
Svenja Peters, MSc
CONTACT
EU.remapcap@umcutrecht.nl

Principal Investigator

Steve Webb, Prof
STUDY_CHAIR
Monash University, Study Chair REMAP-CAP Australia
Colin McArthur, Dr
STUDY_CHAIR
Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
Marc Bonten, Prof
STUDY_CHAIR
UMC Utrecht, Study Chair REMAP-CAP Europe
Lennie Derde, MD
STUDY_CHAIR
UMC Utrecht, Coordinating Investigator REMAP-CAP Europe
John Marshall, Prof
STUDY_CHAIR
Unity Health Toronto, Study Chair REMAP-CAP Canada
Derek Angus, Prof
STUDY_CHAIR
University of Pittsburgh Medical Center, Study Chair REMAP-CAP USA

Study Locations (Sites)

University of Florida
Jacksonville, Florida, 32209
United States
Augusta University
Augusta, Georgia, 30912
United States
University of Illinois Health
Chicago, Illinois, 60612
United States
Tulane Medical Center
New Orleans, Louisiana, 70112
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157-1009
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239-3098
United States
University of Pittsburgh Medical Centre
Pittsburgh, Pennsylvania
United States
Brown University - Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: UMC Utrecht

  • Steve Webb, Prof, STUDY_CHAIR, Monash University, Study Chair REMAP-CAP Australia
  • Colin McArthur, Dr, STUDY_CHAIR, Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
  • Marc Bonten, Prof, STUDY_CHAIR, UMC Utrecht, Study Chair REMAP-CAP Europe
  • Lennie Derde, MD, STUDY_CHAIR, UMC Utrecht, Coordinating Investigator REMAP-CAP Europe
  • John Marshall, Prof, STUDY_CHAIR, Unity Health Toronto, Study Chair REMAP-CAP Canada
  • Derek Angus, Prof, STUDY_CHAIR, University of Pittsburgh Medical Center, Study Chair REMAP-CAP USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04-11
Study Completion Date2028-02

Study Record Updates

Study Start Date2016-04-11
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Pneumonia
  • Lung Diseases
  • Respiratory Tract Diseases
  • Respiratory Tract Infections
  • Anti-Bacterial Agents
  • Moxifloxacin
  • Levofloxacin
  • Antibiotics
  • Hydrocortisone
  • Anti-Infective Agents
  • Ceftriaxone
  • Piperacillin-tazobactam
  • Ceftaroline
  • Amoxicillin-clavulanate
  • Oseltamivir
  • COVID-19
  • Influenza
  • Intensive care
  • Critical care
  • SARS-CoV-2
  • Vitamin C
  • Therapeutic Anticoagulation
  • Statin
  • Invasive Mechanical Ventilation
  • Convalescent plasma
  • Eritoran
  • Apremilast
  • DMX-200
  • Ivermectin
  • Baloxavir
  • Tocilizumab
  • Baricitinib
  • Imatinib

Additional Relevant MeSH Terms

  • Community-acquired Pneumonia, Influenza, COVID-19