Adaptive trial in severe pneumonia (REMAP-CAP)

Phase 1

• Conditions: Severe Community Acquired Pneumonia; MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002340-14-ES
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

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
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

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

AB Domain Specific Exclusion Criteria

Received more than 48 hours of IV antibiotic treatment for this index illness
• More than 24 hours has elapsed since ICU admission
• Known hypersensitivity to all of the study drugs in the site randomization schedule
• A specific antibiotic choice is indicated, for example:
o Suspected or proven concomitant infection such as meningitis
o Suspected or proven infection with resistant bacteria where agents being trialed would not be expected to be active. This includes cystic fibrosis, bronchiectasis or other chronic suppurative lung disease where infection with Pseudomonas may be suspected but does not include patients with suspected methicillin-resistant Staphylococcus aureus (MRSA) infection (see MRSA below).
o Febrile neutropenia or significant immunosuppression (including organ or bone marrow transplantation, human immunodeficiency virus (HIV) Infection with CD4 cell count <200 cells/µL, systemic immunosuppressive, systemic corticosteroids comprising prednisolone, or equivalent, =20mg/day for > 4 preceding weeks).
o Suspected melioidosis (tropical sites during melioidosis season – see melioidosis below)
o There is sufficient microbiological information to guide specific antibacterial therapy
• The treating clinician believes that participation in the domain would not be in the best interests of the patient

AB Specific Intervention Exclusion Criteria
1.Known non-serious hypersensitivity to penicillins will result in exclusion from receiving interventions that include piperacillin and amoxicillin
2.Known non-serious hypersensitivity to cephalosporins will result in exclusion from receiving interventions that include ceftriaxone and ceftaroline
3.Known serious hypersensitivity to beta-lactams, including penicillins or cephalosporins, will result in exclusion from interventions that include piperacillin, amoxicillin, ceftriaxone, and ceftaroline.
4.Known hypersensitivity to moxifloxacin or levofloxacin will result in exclusion from moxifloxacin or levofloxacin intervention
5.Known serious hypersensitivity to the macrolide will result in exclusion from interventions that include piperacillin, amoxicillin, ceftriaxone, and ceftaroline.
6.Known or suspected pregnancy will result in exclusion from moxifloxacin or levofloxacin and ceftaroline interventions.

Corticosteroid domain Specific Exclusion Criteria
• Known hypersensitivity to hydrocortisone
• Intention to prescribe systemic corticosteroids for a reason that is unrelated to the current episode of CAP (or direct complications of CAP), such as chronic corticosteroid use before admission, acute severe asthma, or suspected or proven Pneumocystis jiroveci pneumonia
• More than 24 hours have elapsed since ICU admission
• The treating clinician believes that participation in the domain would not be in the best interests of the patient

Corticosteroïde domain Intervention-Specific Exclusions Criteria: not applicable

Macrolide duration doma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified