Individualizing Steroid Use in Pneumonia

NIH Pandemic-Era Grants

Pandemic Era Grants

2024

Document text

Principal Investigator: Yewande  Odeyemi
Organization: MAYO CLINIC ROCHESTER
Fiscal Year: 2024
Award: $169,020
Funding agency: National Heart Lung and Blood Institute

PROJECT SUMMARY/ABSTRACT
Pneumonia is the leading infectious cause of death worldwide. While inflammation is a hallmark pathologic
feature of pneumonia, the use of corticosteroids to blunt the profound inflammatory response remains
undefined. Decades of studies in heterogeneous populations failed to show a consistent benefit, leading to
conflicting guidelines on the use of corticosteroids. Although corticosteroids have been shown to be effective in
COVID-19 pneumonia, the use of corticosteroids in other infectious pneumonia remains unclear with high
variability in clinical practice. This variability in practice presents an opportunity to see how corticosteroid
administration in pneumonia can be optimized and tailored to patient specific characteristics. The objective of
this study is to adapt advanced statistical and machine learning methods to already available robust
observational data from the electronic health record to identify predictors of clinical deterioration and to develop
an individualized treatment rule for steroid use in patients with community acquired pneumonia. This will be
accomplished through three specific aims: 1) To develop and validate a machine learning prediction tool for
in-hospital disease progression, 2) To develop and test an individualized treatment rule (ITR) for steroid use,
and 3) To conduct a single center feasibility clinical trial comparing ITR and biomarker guided corticosteroid
use and dosing to usual care in patients with community acquired pneumonia. We hypothesize that: 1) a
combination of demographics, physiological parameters, clinical and laboratory data will be accurate in
predicting risk of in-hospital disease progression and identifying steroid-responsive patients in whom benefit
from adjunct corticosteroid treatment outweighs potential harm, and 2) ITR and biomarker-guided
corticosteroid use, and dosing will be feasible. This career development award will provide important
preliminary data for future larger clinical trials focused on optimizing corticosteroid use in pneumonia while
training a junior investigator in the essential skills needed to become an independent researcher.

Terms: <21+ years old><ARDS><Acute Respiratory Distress><Acute Respiratory Distress Syndrome><Adoption><Adrenal Cortex Hormones><Adult><Adult ARDS><Adult Human><Adult RDS><Adult Respiratory Distress Syndrome><Anti-Inflammatories><Anti-Inflammatory Agents><Anti-inflammatory><Biological Markers><Biometrics><Biometry><Biostatistics><C-reactive protein><COVID associated pneumonia><COVID crisis><COVID epidemic><COVID induced pneumonia><COVID infected patient><COVID pandemic><COVID patient><COVID pneumonia><COVID positive patient><COVID related pneumonia><COVID-19 associated pneumonia><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 induced pneumonia><COVID-19 infected patient><COVID-19 pandemic><COVID-19 patient><COVID-19 period><COVID-19 pneumonia><COVID-19 positive patient><COVID-19 public health crisis><COVID-19 related pneumonia><COVID-19 viral pneumonia><COVID-19 years><COVID19 patient><COVID19 positive patient><Career Development Awards><Career Development Awards and Programs><Career Development Programs K-Series><Cause of Death><Characteristics><Clinic><Clinical><Clinical Trials><Clinical Trials Design><Complication><Corticoids><Corticosteroids><Coupled><Critical Care><Critical Illness><Critically Ill><Da Nang Lung><Data><Data Science><Demographic Analyses><Demographic Analysis><Deterioration><Disease Progression><Dose><Electronic Health Record><Future><Goals><Grant><Guidelines><Hospital Admission><Hospitalization><Hospitals><Hypoxemia><Individual><Inflammation><Inflammatory Response><Investigation><Investigators><K-Awards><K-Series Research Career Programs><Knowledge><Laboratories><Methodology><O element><O2 element><Outcome><Outcomes Research><Oxygen><Pathologic><Patient Selection><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Personalized medical approach><Physiologic><Physiological><Pneumonia><Population><Population Heterogeneity><Pragmatic clinical trial><Predicting Risk><Proteins, specific or class, C-reactive><Recovery><Research><Research Career Program><Research Personnel><Researchers><Resolution><Retrospective cohort><Risk><SARS-CoV-2 associated pneumonia><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 induced pneumonia><SARS-CoV-2 infected patient><SARS-CoV-2 pandemic><SARS-CoV-2 patient><SARS-CoV-2 pneumonia><SARS-CoV-2 positive patient><SARS-CoV-2 related pneumonia><SARS-CoV-2 viral pneumonia><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Sample Size><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Shock Lung><Steroid Compound><Steroids><Stiff lung><Testing><Time><Training><acute COVID-19><acute SARS-CoV-2 infection><acute hypoxemic respiratory failure><acute hypoxic respiratory failure><acute onset hypoxemic respiratory failure><acute phase of COVID-19><acute phase of SARS-CoV-2 infection><adulthood><bio-markers><biologic marker><biomarker><care as usual><clinical practice><clinical predictors><community acquired pneumonia><community associated pneumonia><coronavirus disease 2019 associated pneumonia><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 induced pneumonia><coronavirus disease 2019 infected patient><coronavirus disease 2019 pandemic><coronavirus disease 2019 patient><coronavirus disease 2019 pneumonia><coronavirus disease 2019 positive patient><coronavirus disease 2019 public health crisis><coronavirus disease 2019 related pneumonia><coronavirus disease associated pneumonia><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease induced pneumonia><coronavirus disease infected patient><coronavirus disease pandemic><coronavirus disease patient><coronavirus disease pneumonia><coronavirus disease positive patient><coronavirus disease related pneumonia><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><coronavirus disease-19 patient><coronavirus disease-19 pneumonia><coronavirus patient><customized therapy><customized treatment><demographics><diverse populations><effectiveness testing><electronic health care record><electronic health data><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><evidence base><experience><forecasting risk><heterogeneous population><hypoxemic><implementation science><improved><individualized approach><individualized medicine><individualized patient treatment><individualized therapeutic strategy><individualized therapy><individualized treatment><machine learning based method><machine learning based prediction model><machine learning based predictive model><machine learning method><machine learning methodologies><machine learning prediction><machine learning prediction model><machine statistical learning><multidisciplinary><patient infected with COVID><patient infected with COVID-19><patient infected with SARS-CoV-2><patient infected with coronavirus disease><patient infected with coronavirus disease 2019><patient infected with severe acute respiratory syndrome coronavirus 2><patient oriented outcomes><patient response><patient specific response><patient specific therapies><patient specific treatment><patient with COVID><patient with COVID-19><patient with COVID19><patient with SARS-CoV-2><patient with coronavirus disease><patient with coronavirus disease 2019><patient with severe acute respiratory distress syndrome coronavirus 2><personalized approach><pneumonia due to COVID><pneumonia due to COVID-19><pneumonia due to SARS-CoV-2><pneumonia due to coronavirus disease><pneumonia due to coronavirus disease 2019><pneumonia due to severe acute respiratory syndrome coronavirus 2><pneumonia in COVID><pneumonia in COVID-19><pneumonia in SARS-CoV-2><pneumonia in coronavirus disease><pneumonia in coronavirus disease 2019><pneumonia in severe acute respiratory syndrome coronavirus 2><population diversity><precision approach><predict risk><predict risks><predicted risk><predicted risks><predicting risks><predictive risk><predictive tools><predicts risk><primary outcome><prognostic><prognostic tool><resolutions><responsive patient><risk prediction><risk predictions><severe acute respiratory syndrome coronavirus 2 associated pneumonia><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><severe acute respiratory syndrome coronavirus 2 induced pneumonia><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 pneumonia><severe acute respiratory syndrome coronavirus 2 positive patient><severe acute respiratory syndrome coronavirus 2 related pneumonia><skills><statistical and machine learning><success><tailored approach><tailored medical treatment><tailored therapy><tailored treatment><treatment as usual><trial comparing><unique treatment><usual care><wet lung>