Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: Methylprednisolone; Usual Care
Intervention description: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.; Usual care as determined by the patients treatment team.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia, steroid, COVID-19, SARS CoV-2

Summary:

      This research study is being done to determine the appropriate dose of steroids and the
      appropriate duration for steroid use to reduce inflammation in severe pneumonia needing a
      form of breathing support. This study seeks to compare usual care to a unique
      (individualized) dosing strategy. A marker of inflammation in the body will be measured in
      blood samples. This marker of inflammation is called C- reactive protein. The overall goal is
      to identify patients that will benefit most from steroid use and decrease use of steroids.
      The information collected from this study may provide information that may improve management
      of patients with severe pneumonia requiring a form of breathing support.
    

Eligibility criteria:

        For the Pneumonia arm of the study:

        Inclusion Criteria:

          -  Patients admitted to hospital with community acquired pneumonia.

          -  Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).

        Exclusion Criteria:

          -  Contraindications or unwilling to use steroids by patient or provider

          -  Refractory septic shock defined as a requirement of norepinephrine dose or equivalent
             above >0.1 microgram/kilogram/minute or 2 or more vasopressors

          -  Pre-admission chronic use of steroids or other immunosuppressive medications

          -  Adrenal insufficiency

          -  Comfort care

          -  Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and
             HIV positive with a CD4 count <100

          -  Recent or past history of bone marrow or solid organ transplantation

          -  Hospital admission in the previous 30 days

          -  Suspected flare of Interstitial lung disease (infectious and non-infectious)

          -  Positive influenza testing or high suspicion for influenza

        For the COVID-19 arm of the study:

        Inclusion Criteria:

          -  Patients admitted to hospital with COVID-19 pneumonia (high suspicion or confirmed by
             positive SARS CoV-2 testing).

          -  Acute respiratory failure SpO2/FiO2 < 315 (SpO2<90% on room air or <97% on 2L NC).

        Exclusion Criteria:

          -  Contraindications or unwilling to use steroids by patient or provider

          -  Refractory septic shock defined as a requirement of norepinephrine dose or equivalent
             above >0.1 microgram/kilogram/minute or 2 or more vasopressors

          -  Pre-admission chronic use of steroids or other immunosuppressive medications

          -  Adrenal insufficiency

          -  Comfort care

          -  Leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and
             HIV positive with a CD4 count <100

          -  Recent or past history of bone marrow or solid organ transplantation

          -  Suspected flare of Interstitial lung disease (infectious and non-infectious)

          -  Positive influenza testing or high suspicion for influenza