Actively Recruiting
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
Eligibility Criteria
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)
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
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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
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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