ARrest RESpiraTory Failure From PNEUMONIA

• Status: Enrolling by invitation
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Budesonide; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Severe Pneumonia defined as hospitalization for acute (< 7 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 < 35oC or > 38oC or WBC > or < upper or lower limits for site or procalcitonin > 0.5 mcg/L), or known current immunosuppression preventing inflammatory response.

and

• Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.

and

• No clinical suspicion for COVID-19 pneumonia or confirmed negative test for SARS CoV2 infection.

Exclusion Criteria:

• Inability to obtain consent within 24 hours of presentation to emergency room

• Intubation (or impending intubation) prior to enrollment (This does not include those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment)

• A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments)

• 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 known 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