Status:
COMPLETED
Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia
Lead Sponsor:
Mayo Clinic
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is being done to determine the appropriate dose of steroids and the appropriate duration for steroid use to reduce inflammation in severe pneumonia needing a form of breathing supp...
Detailed Description
This is a two-arm single-center pilot phase II clinical trial. Patients will be screened at the time of hospital admission and will be required to be enrolled within the clinical trial within 48 hours...
Eligibility Criteria
Inclusion
- For the Pneumonia arm of the study:
- Patients admitted to hospital with community acquired pneumonia.
- Acute respiratory failure SpO2/FiO2 \< 315 (SpO2\<90% on room air or \<97% on 2L NC).
Exclusion
- Contraindications or unwilling to use steroids by patient or provider
- Refractory septic shock defined as a requirement of norepinephrine dose or equivalent above \>0.1 microgram/kilogram/minute or 2 or more vasopressors
- Pre-admission chronic use of steroids or other immunosuppressive medications
- Adrenal insufficiency
- Comfort care
- Leukopenia \<1000/mm or neutropenia \<500/mm (except if attributable to pneumonia) and HIV positive with a CD4 count \<100
- Recent or past history of bone marrow or solid organ transplantation
- Hospital admission in the previous 30 days
- Suspected flare of Interstitial lung disease (infectious and non-infectious)
- Positive influenza testing or high suspicion for influenza
- For the COVID-19 arm of the study:
- Inclusion Criteria:
- Patients admitted to hospital with COVID-19 pneumonia (high suspicion or confirmed by positive SARS CoV-2 testing).
- Acute respiratory failure SpO2/FiO2 \< 315 (SpO2\<90% on room air or \<97% on 2L NC).
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03852537
Start Date
December 2 2019
End Date
November 17 2020
Last Update
September 16 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905