Adaptive trial in severe pneumonia (REMAP-CAP)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 8000

Inclusion Criteria

General REMAP-CAP Inclusion Criteria:
1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with
a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND
b. Radiological evidence of new onset infiltrate of infective origin (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:
a. Non-invasive or invasive ventilatory support;
b. Receiving infusion of vasopressor or inotropes or both

COVID-19:
In order to be eligible to participate in the pandemic aspects of REMAP-CAP, a patient must meet the following criteria:
1. Adult patient admitted to hospital with acute illness due to suspected or proven pandemic infection.

This extension of the platform-level inclusion criteria can apply to patients admitted to an ICU or a ward. In association with the involvement of different clinical teams, the domains and interventions that are available for patients admitted to a ward compared with those admitted to an ICU are permitted to be, but do not have to be, different.

Further domain specific eligibility criteria may apply depending on the domain in question. Please refer to the respective Domain Specific Appendix to to the protocol for details.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000

Exclusion Criteria

General REMAP-CAP Exclusion Criteria:
1. Healthcare-associated pneumonia:
a. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
b. 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

COVID-19:
In order to be eligible to participate in the pandemic aspects of REMAP-CAP, a patient must meet the following criteria:
1. Adult patient admitted to hospital with acute illness due to suspected or proven pandemic infection

Further domain specific eligibility criteria may apply depending on the domain in question. Please refer to the respective Domain Specific Appendix to to the protocol for details.