ARrest RESpiraTory Failure From PNEUMONIA
Trial ID or NCT#
NCT04193878
Status
RECRUITING
Purpose
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)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- Patients 18 years or older with Severe pneumonia defined as: 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) AND 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:
- - 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) - Intubation (or impending intubation) prior to enrollment a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded - 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
Investigator(s)
Joseph Levitt, MD, MS
Pulmonary critical care specialist,
Pulmonologist,
Critical care specialist
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)
Angela Rogers
Pulmonary critical care specialist,
Pulmonologist,
Critical care specialist
Associate Professor of Medicine (Pulmonary and Critical Care)
Contact us to find out if this trial is right for you.
Contact
Joe Levitt, MD
650-723-6381
View on ClinicalTrials.gov
