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

ID#: NCT07039019

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Early Phase 1

Recruitment Status: Recruiting

Start Date: June 04, 2025

End Date: November 19, 2026

Contact Information:
Axel Duval, MD
212-824-8546
Summary: 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
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