TERMINATED

ARrest RESpiraTory Failure From PNEUMONIA

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Conditions

PneumoniaHypoxemiaAcute Respiratory FailureCOVID-19 Pneumonia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)

Quick Facts

Study Start:2020-06-01
Study Completion:2025-07-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04193878

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  2. 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
  3. 2. Known current immunosuppression preventing inflammatory response, OR
  4. 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)
  1. * 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)
  2. * Intubation (or impending intubation) prior to enrollment
  3. * 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)
  4. * Chronic systemic steroid therapy equivalent to \>10 mg prednisone
  5. * COVID-19 positive patients receiving \> 6 mg dexamethasone (40 mg prednisone equivalent dose) except for stress dose steroids for septic shock
  6. * Non-COVID-19 pneumonia patients receiving systemic steroid \> 10 mg prednisone except for stress dose steroids for septic shock
  7. * Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
  8. * Not anticipated to survive \> 48 hours or not expected to require \> 48 hours of hospitalization
  9. * Contraindication or allergy to inhaled corticosteroids or beta-agonists
  10. * 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
  11. * Patients with K+ \< 3.0 will be potentially eligible for enrollment after the condition has resolved
  12. * Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed)
  13. * Pregnancy
  14. * Incarcerated individual
  15. * Physician refusal of consent to protocol
  16. * Patient/surrogate refusal of consent to protocol

Contacts and Locations

Principal Investigator

Joseph Levitt, MD
PRINCIPAL_INVESTIGATOR
Stanford University
Emir Festic, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

University of Alabama Birmingham - Main & Highlands
Birmingham, Alabama, 35233
United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
United States
University of Arizona - Main & South Campus
Tucson, Arizona, 85724
United States
Stanford University
Palo Alto, California, 94304
United States
University of Florida
Gainesville, Florida, 32611
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
United States
Tulane University - Main & BUMC
New Orleans, Louisiana, 70112
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Johns Hopkins University - Main Campus & Bayview
Baltimore, Maryland, 21205
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
New York University - Langone Health
New York, New York, 10016
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Joseph Levitt, MD, PRINCIPAL_INVESTIGATOR, Stanford University
  • Emir Festic, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-01
Study Completion Date2025-07-22

Study Record Updates

Study Start Date2020-06-01
Study Completion Date2025-07-22

Terms related to this study

Additional Relevant MeSH Terms

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