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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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 corticosteroids.

This is a pilot study. Although there are forty people expected to take part in this research study based on institutional data, the number of patients included in the study will be determined by the number of patients with non-specific pleuritis diagnosed during the study period.

Eligibility

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

Study details
    Pleuritis
    Non-specific

NCT07039019

Icahn School of Medicine at Mount Sinai

15 October 2025

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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