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ARREST: ARrest RESpiraTory Failure From PNEUMONIA

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04193878
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Institutes of Health (NIH) (NIH)
600
Enrollment
12
Locations
2
Arms
63
Anticipated Duration (Months)
50
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inhaled budesonide and formoterol
  • Drug: Inhaled placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

4 ml aerosolized 0.9% saline every 12 hours x 10 doses

Drug: Inhaled placebo
aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
Other Names:
  • aerosolized 0.9% saline

    		•
    Active Comparator: Intervention

    aerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 10 doses

    Drug: Inhaled budesonide and formoterol
    aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
    Other Names:
  • Pulmicort Respules (budesonide) and Perforomist (formoterol)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute respiratory failure (ARF) [within 7 days of randomization]

      High flow nasal cannula (HFNC) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours

    Secondary Outcome Measures

    1. Hospital length of stay [within 60 days of randomization]

    2. Duration of need for supplemental oxygen [within 60 days of randomization]

    3. Proportion of patients intubated for respiratory failure [Within 7 days of randomization]

    4. Oxygen failure free days to day 28 [Until Day 28]

    5. Progression to systemic steroid therapy for pneumonia [during course of the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients 18 years or older with

    1. Severe Pneumonia defined as hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan AND 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 known current immunosuppression preventing inflammatory response.

    AND

    1. Hypoxemia defined as new requirement for daytime supplemental oxygen with SpO2 < 92% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or non-invasive ventilation regardless of SpO2 at enrollment. Patients admitted with pneumonia but not meeting criteria for hypoxemia will be followed for up to 24 hours from ED admission to enrolling hospital to assess for development of qualifying hypoxemia.
    Exclusion Criteria:

    1. Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation)

    2. Intubation (or impending intubation) prior to enrollment

    1. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded

    1. 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)

    2. Chronic systemic steroid therapy equivalent to >10 mg prednisone

    3. COVID-19 positive patients receiving > 6 mg dexamethasone (30 mg prednisone equivalent dose)

    4. Non-COVID-19 pneumonia patients receiving systemic steroid > 10 mg prednisone except for stress dose steroids for septic shock

    5. Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome

    6. Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization

    7. Contraindication or allergy to inhaled corticosteroids or beta-agonists

    8. 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

    9. K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved

    10. Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed)

    11. Pregnancy

    12. Incarcerated individual

    13. Physician refusal of consent to protocol

    14. Patient/surrogate refusal of consent to protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama-Birmingham Birmingham Alabama United States 35233
    2 Mayo Clinic - Scottsdale Scottsdale Arizona United States 85259
    3 University of Arizona - Main & South Campus Tucson Arizona United States 85724
    4 Stanford University Palo Alto California United States 94304
    5 University of Florida Gainesville Florida United States 32611
    6 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
    7 Tulane University New Orleans Louisiana United States 70112
    8 University of Maryland Baltimore Maryland United States 21201
    9 Johns Hopkins University - Main Campus & Bayview Baltimore Maryland United States 21205
    10 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    11 New York University - Langone Health New York New York United States 10016
    12 Temple University Philadelphia Pennsylvania United States 19140

    Sponsors and Collaborators

    • Stanford University
    • National Heart, Lung, and Blood Institute (NHLBI)
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Joseph Levitt, MD, Stanford University
    • Principal Investigator: Emir Festic, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joseph Levitt, MD, Clinical Assistant Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT04193878
    Other Study ID Numbers:
    • 53599
    • 1UG3HL141722-01A1
    First Posted:
    Dec 10, 2019
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia
    Respiratory Insufficiency
    Hypoxia
    Budesonide
    Formoterol Fumarate

    Study Results

    No Results Posted as of Aug 10, 2022