Prednisone to prevent recurrence of non-specific pleuritis
Pilot, RandOmized Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
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 |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT07039019 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: There is limited prior research specifically testing corticosteroids to prevent recurrence in non-specific pleuritis, so this is largely a novel, small pilot effort.
Eligibility criteria
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 this trial is running
New York, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.