ARrest RESpiraTory Failure From PNEUMONIA

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 < 4000 or > 11,000 or procalcitonin > 0.5 mcg/L).
  • 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.

Exclusion Criteria: 

  • 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).
  • Contraindication or known allergy to inhaled corticosteroids or beta-agonists.
  • Inability to obtain consent within 12 hours of meeting entry criteria.
  • 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.
  • Do Not Intubate order but does not include a "Do Not Resuscitate" order.
  • 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.
  • Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours, or K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved.
  • Younger than 18 years of age.
  • Pregnancy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ognjen Gajic, M.D.

Open for enrollment

Contact information:

Amy Amsbaugh R.R.T., L.R.T.

(507)538-7538

Amsbaugh.Amy@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Emir Festic, M.D., M.S.

Open for enrollment

Contact information:

Samantha Eilerman

(904) 953-3523

Eilerman.Samantha@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rodrigo Cartin-Ceba, M.D.

Open for enrollment

Contact information:

Leena Abraham R.N.

(480) 342-6750

Abraham.Leena@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20491944

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