Individualizing Corticosteroid Use in Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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Individualizing Corticosteroid Use in Pneumonia

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>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. | |
| Experimental: Individualized dosing strategy<br>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. | Drug: Dexamethasone<br>* Administered intravenously or orally based on daily CRP values and CRP corticosteriod dosing algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to individual treatment rule and CRP-guided corticosteroid treatment | Number of eligible subjects that adhered to the timely initiation and daily corticosteroid treatment | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Disease Progression | Progression on the WHO clinical progression scale from 4 to 10 | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | 
| Need for Advanced Respiratory Support | Number of participants to require use of advanced respiratory support (high flow nasal cannula, non-invasive positive pressure ventilation and invasive ventilation) | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | 
| Advanced respiratory support free days | Number of days without need for high flow nasal cannula, non-invasive positive pressure ventilation and invasive ventilation within 28 days of need for support. Assign 0 if death occurs with 28 days. | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | 
| ICU and hospital free days | Number of days patient was alive outside the ICU or hospital within the first 28 days of admission | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | 
| Mortality | Number of subject deaths | First 5 days of hospitalization or until hospital discharge (whichever is sooner) |