ARrest RESpiraTory Failure From PNEUMONIA

Description

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

Conditions

Pneumonia, Hypoxemia, Acute Respiratory Failure, COVID-19 Pneumonia

Study Overview

Study Details

Study overview

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)

ARrest RESpiraTory Failure From PNEUMONIA

Condition
Pneumonia
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham - Main & Highlands, Birmingham, Alabama, United States, 35233

Scottsdale

Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States, 85259

Tucson

University of Arizona - Main & South Campus, Tucson, Arizona, United States, 85724

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Gainesville

University of Florida, Gainesville, Florida, United States, 32611

Jacksonville

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States, 32224

New Orleans

Tulane University - Main & BUMC, New Orleans, Louisiana, United States, 70112

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins University - Main Campus & Bayview, Baltimore, Maryland, United States, 21205

Rochester

Mayo Clinic - Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum production, or dyspnea), AND 2. Radiographic evidence of pneumonia by chest radiograph or CT scan, AND 3. One of the following:
  • 1. Evidence of systemic inflammation (temperature \< 35◦C or \> 38◦C OR WBC \> or \< upper or lower limits for site OR procalcitonin \> 0.5 mcg/L), OR
  • 2. Known current immunosuppression preventing inflammatory response, OR
  • 3. High clinical suspicion of pneumonia with microbiologic confirmation of infection. Microbiologic confirmation will include a positive nasal swab for a known respiratory virus; a sputum culture growing a likely pathogenic organism plus moderate or greater WBCs (not required for immunocompromised patients); or a positive blood culture with a likely pathogenic organism - e.g., ¼ vials with S. Epidermidis would NOT qualify)
  • * Inability to randomize within 48 hours of presentation to enrolling hospital (randomization beyond 24 hours will be limited to patients with persistent hypoxemia defined by an SpO2 \< 97% while on \> 3L/min O2)
  • * Intubation (or impending intubation) prior to enrollment
  • * A condition requiring inhaled corticosteroids or beta-agonists (patients receiving inhaled beta-agonists in the ED without an established indication will be eligible if treating clinician is willing to discontinue subsequent treatments)
  • * Chronic systemic steroid therapy equivalent to \>10 mg prednisone
  • * COVID-19 positive patients receiving \> 6 mg dexamethasone (40 mg prednisone equivalent dose) except for stress dose steroids for septic shock
  • * Non-COVID-19 pneumonia patients receiving systemic steroid \> 10 mg prednisone except for stress dose steroids for septic shock
  • * Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
  • * Not anticipated to survive \> 48 hours or not expected to require \> 48 hours of hospitalization
  • * Contraindication or allergy to inhaled corticosteroids or beta-agonists
  • * Patients with heart rate \> 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours will be potentially eligible for enrollment after the condition has resolved
  • * Patients with K+ \< 3.0 will be potentially eligible for enrollment after the condition has resolved
  • * Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed)
  • * Pregnancy
  • * Incarcerated individual
  • * Physician refusal of consent to protocol
  • * Patient/surrogate refusal of consent to protocol

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Joseph Levitt, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Emir Festic, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-08-31