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OpenTrials
Completed

NCT Number: NCT05334316

Individualizing Corticosteroid Use in Pneumonia

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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

Primary outcomes

  1. Adherence to individual treatment rule and CRP-guided corticosteroid treatment

    Time frame: 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 outcomes

  1. In-hospital Disease Progression

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

    Progression on the WHO clinical progression scale from 4 to 10

  2. Need for Advanced Respiratory Support

    Time frame: 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)

  3. Advanced respiratory support free days

    Time frame: 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.

  4. ICU and hospital free days

    Time frame: 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

  5. Mortality

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

    Number of subject deaths

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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