Corticosteroids in Community Acquired Pneumonia

Vanderbilt University Medical Center

Status and phase

Withdrawn

Phase 2

Conditions

Community-acquired Pneumonia

Cognition Disorder

Treatments

Drug: Placebo

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT04652414

200278

Details and patient eligibility

About

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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 50 years
Hospital admission to ward or ICU (including observation status admissions)
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.
CRP ≥ 15 mg/dL within 24 hours of enrollment

Exclusion criteria

Systemic steroid use within the past 30-days.
Clinical team planning to treat with systemic steroids during this hospitalization independent of the study protocol.
Unable to randomize patient within 24 hours of hospital presentation.
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.)
Unable to follow simple commands or non-verbal prior to this acute illness.
Pre-existing severe dementia, defined as an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score ≥ 4.12.
Concomitant acute decompensated heart failure requiring intravenous diuretics
Serum sodium > 145 mEq/L (hypernatremia) or potassium < 3.5 mEq/L (hypokalemia) at screening and randomization
Systolic blood pressure > 180 mmHg or a diastolic blood pressure > 100 mmHg at the start and end of screening.
Any history of diabetes mellitus, having a serum blood glucose > 250 mg/dL, or requiring an anti-diabetic medication (e.g., insulin)
Previous allergic or adverse reaction to a corticosteroid
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.
Cystic fibrosis
Active cancer, defined as new diagnosis or treatment for cancer in the past 6 months.
Any history of adrenal insufficiency
Substance abuse (alcohol, opioid, benzodiazepines, methamphetamines, cocaine) within the past year
Any history of hospitalizations due to psychiatric illnesses within the past year
Gastro-intestinal bleeding treated with hospital admission and/or blood transfusion within the past 3 months.
Pre-existing medical condition resulting in a life expectancy < 6 months.
Clinical team does not believe the patient should enter the study due to concerns about potential steroid-related complications.
Alternative non-pneumonia illness accounts for the acute clinical or radiographic findings that meet the study's inclusion criteria.
Unable to take the enteral study medicine by mouth or tube
Prior enrollment in this study at any time
Non-English speaking
Confirmed or suspected COVID-19 as the cause of the patient's acute illness -