TerminatedPhase 3

ARrest RESpiraTory Failure From PNEUMONIA

Stopped: Per DSMB's review of interim analysis, the study has reached the pre-specified futility criteria

United States465 participantsStarted 2020-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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, OR
✓. 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)

What they're measuring

Acute respiratory failure (ARF)

Timeframe: within 7 days of randomization

Trial details

NCT IDNCT04193878

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-22

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