Pneumonia
Conditions
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.
Interventions
DRUGDexamethasone
Administered intravenously or orally based on daily CRP values and CRP corticosteroid dosing algorithm
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to individual treatment rule and CRP-guided corticosteroid treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Disease Progression | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | Progression on the WHO clinical progression scale from 4 to 10 |
| Need for Advanced Respiratory Support | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | Number of participants to require use of advanced respiratory support (high flow nasal cannula, non-invasive positive pressure ventilation and invasive ventilation) |
| Advanced respiratory support free days | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | 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. |
| ICU and hospital free days | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | Number of days patient was alive outside the ICU or hospital within the first 28 days of admission |
| Mortality | First 5 days of hospitalization or until hospital discharge (whichever is sooner) | Number of subject deaths |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYewande Odeyemi, MBBS
Mayo Clinic
Outcome results
None listed