Individualizing Corticosteroid Use in Pneumonia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Adherence to individual treatment rule and CRP-guided corticosteroid treatment
Study Overview
Brief Summary
In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in pneumonia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalized adult (≥ 18 years) patients.
- •Community acquired pneumonia.
Exclusion Criteria
- •Contraindications or unwillingness to use corticosteroids by patient or provider.
- •History of adrenal insufficiency, septic shock, or another absolute indication for steroid use.
- •Suspected pulmonary vasculitis or other autoimmune pulmonary disorder.
- •Positive pregnancy test
- •Comfort care.
Arms & Interventions
Individualized dosing strategy
Biomarker guided corticosteroid use. Initiation of corticosteroid will be recommended based on the an individual treatment rule (ITR) and subsequent dosing of corticosteroid will be recommended based on daily CRP values till CRP <50 mg/L (according to a prespecified C-reactive protein-guided dosing algorithm). Corticosteroid dose and duration were determined by serial CRP measurements
The approved protocol included CRP-guided corticosteroid dosing as a prespecified contingency strategy if a clinically actionable individualized treatment rule could not be developed. The trial therefore proceeded with the CRP-guided corticosteroid strategy
Intervention: Dexamethasone (Drug)
Usual Care Group
Usual care as determined by the patient's primary team. Initiation and daily dosing of corticosteroid treatment will be based on clinicians' preference and clinicians.
Outcomes
Primary Outcomes
Adherence to individual treatment rule and CRP-guided corticosteroid treatment
Time Frame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Number of eligible subjects that adhered to the timely initiation and daily corticosteroid treatment
Secondary Outcomes
- In-hospital Disease Progression(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- Need for Advanced Respiratory Support(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- ICU and hospital free days(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- Advanced respiratory support free days(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- Mortality(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
Investigators
Yewande Odeyemi, MD
Principal Investigator
Mayo Clinic