Individualizing Corticosteroid Use in Pneumonia

Pneumonia Clinical Trial

Official title:

Individualizing Corticosteroid Use in Pneumonia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05334316
• Other study ID #: 21-009032
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Dexamethasone
Administered intravenously or orally based on daily CRP values and CRP corticosteriod dosing algorithm

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Mortality	Number of subject deaths	First 5 days of hospitalization or until hospital discharge (whichever is sooner)