Individualizing Corticosteroid Use in Pneumonia

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Pneumonia

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05334316

21-009032

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Dexamethasone