Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07039019

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-06-26

40

Participants Needed

2

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with non-specific pleuritis diagnosed by pleural biopsy
  • Negative autoimmune blood tests (ANA, ANCA, anti-DS DNA, anti-SS A/B, anti-centromere, RF, anti-CCP)
Not Eligible

You will not qualify if you...

  • Chronic or fibrinous pleuritis
  • Positive autoimmune blood tests
  • Contraindications to corticosteroids
  • Presence of empyema
  • Currently taking corticosteroids or immunosuppressive drugs for other reasons
  • Unable to give informed consent due to cognitive, neurological, or psychiatric issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

2

Mount Sinai Morningside

New York, New York, United States, 10029

Actively Recruiting

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Research Team

A

Axel Duval, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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