Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)

Phase 1

Recruiting

Conditions: MedDRA version: 23.0Level: PTClassification code: 10084268Term: COVID-19 Class: 100000004862
Severe influenza, Severe and moderate COVID-19 infection., Severe community acquired pneumonia (CAP)
MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumonia Class: 10021881
MedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: CTIS2023-507889-89-00

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 3246

Inclusion Criteria

Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND radiological evidence of new onset infiltrate of infective origin (in patients with pre-existing radiological changes, evidence of new infiltrate), Up to 48 hours after ICU admission, receiving organ support with Non-invasive or invasive ventilatory support AND/OR receiving infusion of vasopressor or inotropes or both, For patients in the pandemic stratum: Adult patients admitted to hospital with acute illness due to suspected or proven pandemic infection, Additional domain-specific inclusion criteria are specified in a Domain Specific Appendix (DSA).

Exclusion Criteria

For CAP and Pandemic strata: 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., For CAP and Pandemic strata: Previous participation in this REMAP within the last 90 days, For CAP stratum only: Healthcare-associated pneumonia: prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days OR resident of a nursing home or long-term care facility., For Pandemic stratum only: Patient is expected to be discharged from hospital today or tomorrow, For Pandemic stratum only: More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection, Additional specific exclusion criteria are specified in a Domain Specific Appendix (DSA)