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Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis

RecruitingEARLY Phase 1Ages 18 Years - anyAllIcahn School of Medicine at Mount Sinai
NCT07039019 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions. There is no established treatment to prevent recurrence, and this study seeks to determine whether steroids reduce fluid buildup or cause complications. There will be two groups: one receiving corticosteroids (standard of care in the institution) and one not receiving corticosteroids (intervention group). The participation will last approximately 6 months, with in-person visits every 2 weeks for the first month, then monthly, along with possible telephone follow-ups. The study will monitor for pleural effusion recurrence, need for additional procedures, and potential side effects of corti

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📋 Eligibility rules (as published)
Inclusion Criteria: * All adult patients with diagnosis of non-specific pleuritis as determined by pleural biopsy with a negative serologic autoimmune profile (ANA, ANCA, anti-DS DNA, anti-SS A/B, anti-centromere, RF, anti-CCP) are eligible Exclusion Criteria: * Chronic/fibrinous pleuritis * Positive autoimmune serologic workup * A contraindication to corticosteroids * Empyema * Patients already receiving corticosteroids or other immunosuppressive medications for any other indication * Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment
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What it tests

  • Corticosteroid
  • No Corticosteroid
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Where

2 sites
Mount Sinai Hospital
New York, United States
Mount Sinai Morningside
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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