Corticosteroids in Community Acquired Pneumonia

NCT ID: NCT04652414

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-07-30

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.

Conditions

Community-acquired Pneumonia; Cognition Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Prednisone

Patients randomized to the intervention arm will receive prednisone 50mg PO daily for 7 days.

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Prednisone 50mg will be administered enterally for 7 days.

Placebo

Patients will receive matching placebo PO daily for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This is a matching placebo to prednisone.

Interventions

Prednisone

Prednisone 50mg will be administered enterally for 7 days.

Intervention Type: DRUG

Placebo

This is a matching placebo to prednisone.

Intervention Type: DRUG

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

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 -

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jin H. Han

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Han, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Wesley Self, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

200278

Identifier Type: -

Identifier Source: org_study_id