Individualizing Corticosteroid Use in Pneumonia

NCT05334316 | Completed Phase 2 FDA Drug

• 1 other identifier: 21-009032
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• Advanced respiratory support free days

  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)

• Mortality

  First 5 days of hospitalization or until hospital discharge (whichever is sooner)

Study Arms (2)

Usual Care Group

NO INTERVENTION

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.

Individualized dosing strategy

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Administered intravenously or orally based on daily CRP values and CRP corticosteroid dosing algorithm

Individualized dosing strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized adult (≥ 18 years) patients.
• Community acquired pneumonia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pneumonia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Yewande Odeyemi, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 19, 2022
• Study Start: November 6, 2024
• Primary Completion: April 3, 2026
• Study Completion: April 29, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)