Individualizing Corticosteroid Use in Pneumonia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05334316
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Administered intravenously or orally based on daily CRP values and CRP corticosteroid dosing algorithm

Study Details

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.

Key Dates

Start date
Nov 6, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual Care Group
    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.
  • Experimental: Individualized dosing strategy
    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 Measure

Adherence to individual treatment rule and CRP-guided corticosteroid treatment [ Time Frame: First 5 days of hospitalization or until hospital discharge (whichever is sooner) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55905
Lori A Dahring
[email protected]
507-538-4344
Amy L Amsbaugh
[email protected]

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By research site
Mayo Clinic Rochester· Rochester, MN

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