Community acquired pneumonia, including COVID-19 disease MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862
Conditions
Interventions
Trade Name: ceftriaxone
Product Name: ceftriaxone
Product Code: ceftriaxone
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: ceftriaxone sodium
CAS Number: 73384-59-5
Concentration unit:
Sponsors
University Medical Centre Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patient admitted to an ICU for 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 consolidation (in-patients with pre-existing radiological changes, evidence of new infiltrate) 2. Requiring 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Healthcare-associated pneumonia: a) Prior to this illness, has been an in-patient in any healthcare facility within the last 30 days b) Resident of a nursing home or long term care facility 2. Death is deemed imminent or inevitable during this hospital admission 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 Patients will be deemed eligible for each treatment domain if they don´t meet any of the following domain specific exclusion criteria Antibiotic Domain 1. Received more than 48 hours of intravenous antibiotic treatment for this index illness 2. More than 24 hours has elapsed since becoming eligible for this domain 3. Known hypersensitivity to all of the study drugs in the site randomization schedule 4. A specific antibiotic choice is indicated 5. The treating clinician believes that participation in the domain would not be in the best interests of the patient Macrolide Duration Domain (if randomised to a beta-lactam plus macrolide intervention within the Antibiotic Domain) 1. The treating clinician believes that participation in the domain would not be in the best interests of the patient Corticosteroid Domain?????????????????????????????????????? 1. An indication to prescribe systemic corticosteroids for a reason other than community-acquired pneumonia (CAP) (or severe sepsis) such as chronic corticosteroid use before admission, acute severe asthma, or suspected or proven Pneumocystis jiroveci pneumonia 2. Have received an immunomodulatory dose of systemic corticosteroid therapy for more than 24 hours prior to the time of enrolment. An immunomodulatory dose is defined as >20mg of hydrocortisone, >5mg prednisone, >4mg methylprednisolone or >0.8mg dexamethasone per 24 hours. 3. The treating clinician believes that participation in the domain would not be in the best interests of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the REMAP is to identify the effect of a range of interventions to improve outcome of adult patients with severe community acquired pneumonia, who are admitted to ICU. This is defined by all cause mortality at 90 days from the date of enrolment into the trial.;Secondary Objective: The secondary objectives are to determine the effect of the interventions on: ICU Mortality ICU length of stay Hospital length of stay Ventilator free day censored at 28 days Organ failure free days censored at 28 days Survival at 6 months Health Related quality of life at 6 months including EQ5D5L and WHODAS. Secondary Antibiotic Domain-specific endpoints(censored at day 90): 1. Multi-resistant organisms (MRO) colonization/infection: Isolation of multi-drug resistant (MDR) bacteria from clinical or screening specimens 2. C. difficile illness based on detection from feces using current standard of care diagnostics used at site 3. Serious adverse event (SAE) as defined in CORE protocol Secondary Macrolide Domain-specific endpoints (censored at day 90): 1. Serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death in hospital. 2. Serious Adverse Events (SAE) as defined in CORE protocol ;Primary end point(s): The primary outcome for all domains will be the occurrence of death at 90 days post enrolment. In patients recruited who are suspected to have COVID-19 disease the primary outcome will be “number of days alive and not admitted to ICU up to day 21;Timepoint(s) of evaluation of this end point: The occurrence of death will be collected between day 1 and day 90 from the time of enrolment into the trial until end of the hospital admission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ICU mortality censored at 90 days 2. ICU length of stay censored at 90 days 3. Ventilator free days censored at 28 days 4. Organ failure free days censored at 28 days 5. proportion of intubated patients who receive a tracheostomy censored at 28 days 6. Hospital length of stay censored at 90 days after enrolment 7. Destination at time of hospital discharge 8. Readmission to the index ICU during the index hospitalization in the 90 days following enrolment 9. Survival at 6 months after enrolment 10. HRQol at 6 months after enrolment using the EQ5D 11. Disability status measured at 6 months after enrolment using the WHODAS Secondary Antibiotic Domain-specific endpoints(censored at day 90): 1. Multi-resistant organisms (MRO) colonization/infection: Isolation of multi-drug resistant (MDR) bacteria from clinical or screening specimens 2. C. difficile illness based on detection from feces using current standard of care diagnostics used at site 3. Serious adverse event (SAE) as defined in CORE protocol Secondary Macrolide Domain-specific endpoints (censored at day 90): 1. Serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death in hospital. 2. Serious Adverse Events (SAE) as defined in CORE protocol;Timepoint(s) of evaluation of this end point: 90 days or 6 months after enrolment as applicable. | — |
Countries
Australia, Belgium, Croatia, Finland, France, Germany, Hungary, Ireland, Netherlands, New Zealand, Portugal, Romania, Spain, United Kingdom
Contacts
Public ContactFarah Al-Beidh
ICNARC
Outcome results
None listed