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Corticosteroids in Community Acquired Pneumonia

NCT04652414 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-02-08

No results posted yet for this study

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

Interventions

DRUG

Prednisone

Prednisone 50mg will be administered enterally for 7 days.

DRUG

Placebo

This is a matching placebo to prednisone.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jin Han, MD,MSc · Vanderbilt University Medical Center

  • Wesley Self, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-07-30
Completion
2022-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652414 on ClinicalTrials.gov