Corticosteroids in Community Acquired Pneumonia

NCT04652414 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 200278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  1.5 years

Secondary Outcomes (15)

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

  6-months

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

  3-days

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

  7-days

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

  30-days

• Quality of life as measured by the EQ-5D-5L

  6-months

Study Arms (2)

Prednisone

EXPERIMENTAL

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

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Patients will receive matching placebo PO daily for 7 days.

Drug: Placebo

Interventions

Prednisone DRUG

Prednisone 50mg will be administered enterally for 7 days.

Prednisone

Placebo DRUG

This is a matching placebo to prednisone.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Cognition Disorders

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jin Han, MD,MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Wesley Self, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)