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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 resulting in critical illness.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MJM Bonten; UMC Utrecht
• Collaborators: Australian and New Zealand Intensive Care Research Centre; Berry Consultants; Global Coalition for Adaptive Research; Medical Research Institute of New Zealand; Unity Health; University of Pittsburgh Medical Center
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Apremilast; Aspirin; Ceftaroline fosamil; Ceftriaxone; Cephalosporins; Clavulanic Acid; Clopidogrel; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydroxychloroquine; Interferon beta-1a; Interferon-beta; Interferons; Interleukin 1 Receptor Antagonist Protein; Levofloxacin; Lopinavir; Moxifloxacin; Oseltamivir; Piperacillin; Piperacillin, Tazobactam Drug Combination; Prasugrel Hydrochloride; Ritonavir; Simvastatin; Tazobactam; Ticagrelor

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).