Clinical trial NCT04652414: Corticosteroids in Community Acquired Pneumonia
Official title: Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Community-acquired Pneumonia
Cognition Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Feasibility as determined by the number of subjects who are successfully recruited and complete follow-up
timeFrame: 1.5 years
Secondary outcomes:
measure: Global cognition as measured by the Montreal Cognitive Assessment-Blind (MOCA-Blind)
timeFrame: 6-months
measure: Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
timeFrame: 3-days
measure: Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
timeFrame: 7-days
measure: Severity of pneumonia symptoms as measured by the Community-Acquired Pneumonia Symptom (CAP-Sym) Questionnaire
timeFrame: 30-days
measure: Quality of life as measured by the EQ-5D-5L
timeFrame: 6-months
measure: Basic activities of daily living (ADL) as measured by the Barthel's Index
timeFrame: 6-months
measure: Instrumental ADL as measured by Lawton Instrumental Activities of Daily Living Scale (IADLs)
timeFrame: 6-months
measure: Employment status as characterized by the Outcomes After Critical Illness and Surgery (OACIS) Employment Status Questionnaire
timeFrame: 6-months
measure: Vital status (dead / alive)
timeFrame: Baseline to hospital discharge, approximately 5 days
measure: Vital status (dead / alive)
timeFrame: 6-months
measure: Intensive care unit admission (yes/no)
timeFrame: Baseline to hospital discharge, approximately 5 days
measure: Mechanical ventilation (yes/no)
timeFrame: Baseline to hospital discharge, approximately 5 days
measure: Vasopressor use (yes/no)
timeFrame: Baseline to hospital discharge, approximately 5 days
measure: Pleural drainage (yes/no)
timeFrame: Baseline to hospital discharge, approximately 5 days
measure: Hospital length of stay in (days)
timeFrame: Baseline to hospital discharge, approximately 5 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jin Han, MD,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Wesley Self, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: