Pilot, RandOmized Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Number of patients screened
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients already receiving corticosteroids or other immunosuppressive medications for any other indication
- •Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment
Arms & Interventions
Patients with Corticosteroids
Standard of care (corticosteroids) as per institutional practice. If the treatment is effective, patients continue for another 4 weeks while taking medication to prevent infections. If it's not effective, they begin a gradual dose reduction until stopping.
Intervention: Corticosteroid (Drug)
Patients with No Corticosteroids
Patients will not receive any corticosteroids.
Intervention: No Corticosteroid (Other)
Outcomes
Primary Outcomes
Number of patients screened
Time Frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Screened defined as how many patients are evaluated for participation
Number of patients enrolled
Time Frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Enrolled defined as how many screened patients actually join the study
Number of patients retained
Time Frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Retention defined as how many enrolled patients continue participating over time
Secondary Outcomes
- Rate of recurrence(every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months)
Investigators
Udit Chaddha
Associate Professor
Icahn School of Medicine at Mount Sinai