Individualizing Corticosteroid Use in Pneumonia

Phase 2

Recruiting

• Conditions: Pneumonia
• Interventions: Drug: Dexamethasone

• Registration Number: NCT05334316
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized dosing strategy	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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.
Mortality	First 5 days of hospitalization or until hospital discharge (whichever is sooner)	Number of subject deaths

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States