Evaluating treatments for severe community-acquired pneumonia in ICU patients

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

This study tests different treatment options for ICU patients with severe pneumonia to see which ones work best, including special strategies for those with COVID-19.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UMC Utrecht (Academic / other)
• Locations: 408 sites (Jacksonville, Florida and 407 other locations)
• Trial ID: NCT02735707 on ClinicalTrials.gov

What this trial studies

This clinical trial, known as REMAP-CAP, is designed to evaluate the effectiveness of various treatment strategies for patients admitted to the intensive care unit with severe community-acquired pneumonia. It employs a multifactorial adaptive platform approach, allowing for the simultaneous assessment of multiple therapies, including antibiotics and supportive care. The trial is structured to utilize data from ongoing patients to inform treatment decisions for new participants, enhancing the likelihood of beneficial outcomes. Additionally, it includes a sub-platform specifically for COVID-19 treatments, adapting to the needs of respiratory pandemics.

Who should consider this trial

Good fit: Ideal candidates are adults admitted to an ICU for severe community-acquired pneumonia within 48 hours of hospital admission.

Not a fit: Patients with healthcare-associated pneumonia or those deemed to be imminently dying may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly improve treatment outcomes for patients with severe pneumonia and respiratory infections.

How similar studies have performed: Other studies utilizing adaptive platform designs have shown promise, indicating potential for success in this novel approach.

Eligibility criteria

REMAP-CAP PLATFORM INCLUSION CRITERIA:

1. Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:

   1. symptoms or signs or both that are consistent with lower respiratory tract infection AND
   2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
2. Up to 48 hours after ICU admission, receiving organ support with one or more of:

   1. Non-invasive or Invasive ventilatory support;
   2. Receiving infusion of vasopressor or inotropes or both

PLATFORM EXCLUSION CRITERIA:

1. Healthcare-associated pneumonia:

   1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
   2. Resident of a nursing home or long term care facility
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
3. Previous participation in this REMAP within the last 90 days

REMAP-COVID PLATFORM INCLUSION CRITERIA

1\. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection.

REMAP-COVID 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 today or tomorrow
3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection.
4. Previous participation in this REMAP within the last 90 days

DOMAIN-SPECIFIC ELIGIBLE CRITERIA:

Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org).

Where this trial is running

Jacksonville, Florida and 407 other locations

• University of Florida — Jacksonville, Florida, United States (Recruiting)
• Augusta University — Augusta, Georgia, United States (Not_yet_recruiting)
• University of Illinois Health — Chicago, Illinois, United States (Recruiting)
• Tulane Medical Center — New Orleans, Louisiana, United States (Not_yet_recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
• University of Pittsburgh Medical Centre — Pittsburgh, Pennsylvania, United States (Recruiting)
• Brown University - Rhode Island Hospital — Providence, Rhode Island, United States (Not_yet_recruiting)
• Canberra Hospital — Canberra, Australian Capital Territory, Australia (Recruiting)
• Bankstown-Lidcombe Hospital — Bankstown, New South Wales, Australia (Recruiting)
• Blacktown Hospital — Blacktown, New South Wales, Australia (Recruiting)
• Campbelltown Hospital — Campbelltown, New South Wales, Australia (Recruiting)
• Sutherland Hospital — Caringbah, New South Wales, Australia (Recruiting)
• Concord Hospital — Concord, New South Wales, Australia (Recruiting)
• Dubbo Base Hospital — Dubbo, New South Wales, Australia (Recruiting)
• Northern Beaches Hospital — Frenchs Forest, New South Wales, Australia (Recruiting)
• Nepean Hospital — Kingswood, New South Wales, Australia (Recruiting)
• St. George Hospital — Kogarah, New South Wales, Australia (Recruiting)
• Liverpool Hospital — Liverpool, New South Wales, Australia (Recruiting)
• John Hunter Hospital — Newcastle, New South Wales, Australia (Recruiting)
• Orange Health Service — Orange, New South Wales, Australia (Not_yet_recruiting)
• St Vincent's Hospital Sydney — Sydney, New South Wales, Australia (Recruiting)
• Prince of Wales Hospital — Sydney, New South Wales, Australia (Recruiting)
• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Royal North Shore Hospital — Sydney, New South Wales, Australia (Recruiting)
• Wollongong Hospital — Sydney, New South Wales, Australia (Recruiting)
• Wagga Wagga Base Hospital — Wagga Wagga, New South Wales, Australia (Not_yet_recruiting)
• Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
• Royal Darwin Hospital, — Darwin, Northern Territory, Australia (Not_yet_recruiting)
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia (Not_yet_recruiting)
• The Prince Charles Hospital — Brisbane, Queensland, Australia (Recruiting)
• Mater Hospital Brisbane — Brisbane, Queensland, Australia (Recruiting)
• Princess Alexandra Hospital — Brisbane, Queensland, Australia (Recruiting)
• Caboolture Hospital — Caboolture, Queensland, Australia (Recruiting)
• Queen Elizabeth II Jubilee Hospital — Coopers Plains, Queensland, Australia (Recruiting)
• Logan Hospital — Logan City, Queensland, Australia (Not_yet_recruiting)
• Redcliffe Hospital — Redcliffe, Queensland, Australia (Not_yet_recruiting)
• Rockhampton Hospital — Rockhampton, Queensland, Australia (Not_yet_recruiting)
• Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
• Toowoomba Hospital — Toowoomba, Queensland, Australia (Recruiting)
• Townsville Hospital — Townsville, Queensland, Australia (Recruiting)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• The Queen Elizabeth Hospital — Adelaide, South Australia, Australia (Recruiting)
• Lyell McEwin Hospital — Adelaide, South Australia, Australia (Recruiting)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (Recruiting)
• Launceston Hospital — Launceston, Tasmania, Australia (Recruiting)
• Ballarat Base Hospital — Ballarat, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Cameron Green, MSc

Conditions Community-acquired Pneumonia, Influenza, COVID-19; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Anti-Bacterial Agents; Moxifloxacin; Levofloxacin