Corticosteroids in Community Acquired Pneumonia

Vanderbilt University Medical Center

Overview

This is a single-center, blinded, placebo-controlled pilot RCT evaluating corticosteroids for the treatment of Community Acquired Pneumonia (CAP) that will enroll 100 adults hospitalized with community-acquired pneumonia. The primary goal is to assess the feasibility of proposed trial procedures for use in a subsequent phase III trial powered on 6-month cognitive outcome (MOCA-Blind score). Key outcomes are six-month cognitive and functional status, duration and severity of symptoms, and mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Conditions

Community-acquired Pneumonia Cognition Disorder

Interventions

PrednisoneDRUG

Prednisone 50mg will be administered enterally for 7 days.

PlaceboDRUG

This is a matching placebo to prednisone.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 50 years 2. Hospital admission to ward or ICU (including observation status admissions) 3. Acute pneumonia defined as fulfilling each of the following two criteria: (a) New (\<7-day duration) or worsening symptoms consistent with a lower respiratory tract infection, including ≥ 1 of the following: cough, shortness of breath, chest pain, sputum production, or decline in mental status; (b) Radiographic findings on chest x-ray or CT consistent with acute pulmonary infection, including pulmonary opacities, infiltrates, or pleural effusion. 4. CRP ≥ 15 mg/dL within 24 hours of enrollment Exclusion Criteria: 1. Systemic steroid use within the past 30-days. 2. Clinical team planning to treat with systemic steroids during this hospitalization independent of the study protocol. 3. Unable to randomize patient within 24 hours of hospital presentation. 4. Hospital-acquired pneumonia, defined as development of clinical and radiographic signs of pneumonia as an inpatient in an acute care hospital. (Residence in a nursing home or assisted living facility is not an exclusion criterion.) 5. Unable to follow simple commands or non-verbal prior to this acute illness. 6. Pre-existing severe dementia, defined as an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4.12. 7. Concomitant acute decompensated heart failure requiring intravenous diuretics 8. Serum sodium \> 145 mEq/L (hypernatremia) or potassium \< 3.5 mEq/L (hypokalemia) at screening and randomization 9. Systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 100 mmHg at the start and end of screening. 10. Any history of diabetes mellitus, having a serum blood glucose \> 250 mg/dL, or requiring an anti-diabetic medication (e.g., insulin) 11. Previous allergic or adverse reaction to a corticosteroid 12. Severe immunosuppression, defined as any of the following: HIV with CD4 count \< 200 cells/mm3, absolute neutrophil count \< 500 cells/mm3, solid organ or hematopoietic stem cell transplant with in the past 90 days. 13. Cystic fibrosis 14. Active cancer, defined as new diagnosis or treatment for cancer in the past 6 months. 15. Any history of adrenal insufficiency 16. Substance abuse (alcohol, opioid, benzodiazepines, methamphetamines, cocaine) within the past year 17. Any history of hospitalizations due to psychiatric illnesses within the past year 18. Gastro-intestinal bleeding treated with hospital admission and/or blood transfusion within the past 3 months. 19. Pre-existing medical condition resulting in a life expectancy \< 6 months. 20. Clinical team does not believe the patient should enter the study due to concerns about potential steroid-related complications. 21. Alternative non-pneumonia illness accounts for the acute clinical or radiographic findings that meet the study's inclusion criteria. 22. Unable to take the enteral study medicine by mouth or tube 23. Prior enrollment in this study at any time 24. Non-English speaking 25. Confirmed or suspected COVID-19 as the cause of the patient's acute illness -

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up

Feasibility will be defined as: (a) recruitment and successful protocol completion of 100 patients; (b) corticosteroids being well tolerated, as shown by similar severity and frequency of adverse events in the intervention and placebo groups; (c) successful completion of 6-month cognitive assessments by \>80% of survivors; and (d) the primary cognitive outcome Montreal Cognitive Assessment-Blind (MOCA-Blind) numerically favoring the intervention group with the one-tailed upper 80% confidence interval of the difference in MOCA-Blind between the intervention and placebo groups containing the minimally-important clinical difference (2 points on the MOCA-Blind).

Time frame: 1.5 years

Secondary Outcomes

Global cognition as measured by the Montreal Cognitive Assessment-Blind (MOCA-Blind)

This is a measure of global cognition based on the assessment of attention concentration, memory, language, conceptual thinking, calculations, and orientation. Scores range from 0 to 22 with higher scores indicating better cognition.

Time frame: 6-months

Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire

This is a 18-item scale to determine the presence and severity of pneumonia symptoms. Each item is graded on a 6-point Likert scale. Scores range from 0 to 90 with higher scores indicating more severe symptoms.

Time frame: 3-days

Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire

Time frame: 7-days

Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire

Data from ClinicalTrials.gov

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