Prednisone to prevent recurrence of non-specific pleuritis
Official title: Pilot, RandOmized Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
Run by Icahn School of Medicine at Mount Sinai · NCT07039019 · Data updated 2026-11-12
This study tests whether a short course of prednisone can reduce recurrent fluid buildup in adults with non-specific pleuritis after pleural biopsy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Status | Recruiting |
| Started | May 29, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07039019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with non-specific pleuritis confirmed by pleural biopsy, a negative autoimmune serologic profile, not currently on immunosuppressants, and able to give informed consent.
✕Probably not a fit
Patients with chronic/fibrinous pleuritis, positive autoimmune serologies, empyema, contraindications to corticosteroids, or those already receiving corticosteroids or other immunosuppressants are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized interventional study enrolls adults diagnosed with non-specific pleuritis by pleural biopsy and negative autoimmune serologies. Participants are assigned to receive corticosteroids per the institution's usual approach or to not receive corticosteroids, then followed for approximately six months with in-person visits every two weeks for the first month and monthly thereafter, plus possible telephone follow-ups. The study measures recurrence of pleural effusions, need for additional procedures, and corticosteroid-related side effects. About 40 participants are expected to provide preliminary data on feasibility and potential benefit.
Why it matters
Potential benefit: If prednisone reduces recurrence, patients could have fewer repeat procedures and less discomfort from pleural effusions.
How similar studies have gone: There is limited prior research specifically testing corticosteroids to prevent recurrence in non-specific pleuritis, so this is largely a novel, small pilot effort.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Mount Sinai Hospital
New York, New York, United States Recruiting -
Mount Sinai Morningside
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Udit Chaddha, MBBS — Icahn School of Medicine
- Study coordinator: Axel Duval, MD
- Email: axel.duval@mountsinai.org
- Phone: 212-824-8546
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.