Individualizing Corticosteroid Use in Pneumonia
Primary Purpose
Pneumonia
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care Group
Individualized dosing strategy
Arm 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.
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.
Outcomes
Primary Outcome Measures
Adherence to individual treatment rule and CRP-guided corticosteroid treatment
Number of eligible subjects that adhered to the timely initiation and daily corticosteroid treatment
Secondary Outcome Measures
In-hospital Disease Progression
Progression on the WHO clinical progression scale from 4 to 10
Need for Advanced Respiratory Support
Number of participants to require use of advanced respiratory support (high flow nasal cannula, non-invasive positive pressure ventilation and invasive ventilation)
Advanced respiratory support free days
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.
ICU and hospital free days
Number of days patient was alive outside the ICU or hospital within the first 28 days of admission
Mortality
Number of subject deaths
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334316
Brief Title
Individualizing Corticosteroid Use in Pneumonia
Official Title
Individualizing Corticosteroid Use in Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2024 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm 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.
Arm Title
Individualized dosing strategy
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Administered intravenously or orally based on daily CRP values and CRP corticosteriod dosing algorithm
Primary Outcome Measure Information:
Title
Adherence to individual treatment rule and CRP-guided corticosteroid treatment
Description
Number of eligible subjects that adhered to the timely initiation and daily corticosteroid treatment
Time Frame
First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Secondary Outcome Measure Information:
Title
In-hospital Disease Progression
Description
Progression on the WHO clinical progression scale from 4 to 10
Time Frame
First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Title
Need for Advanced Respiratory Support
Description
Number of participants to require use of advanced respiratory support (high flow nasal cannula, non-invasive positive pressure ventilation and invasive ventilation)
Time Frame
First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Title
Advanced respiratory support free days
Description
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.
Time Frame
First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Title
ICU and hospital free days
Description
Number of days patient was alive outside the ICU or hospital within the first 28 days of admission
Time Frame
First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Title
Mortality
Description
Number of subject deaths
Time Frame
First 5 days of hospitalization or until hospital discharge (whichever is sooner)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yewande Odeyemi, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Individualizing Corticosteroid Use in Pneumonia
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