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

Mount Sinai Health System

Status and phase

Enrolling

Early Phase 1

Conditions

Pleuritis, Non-specific

Treatments

Drug: Corticosteroid

Other: No Corticosteroid

Study type

Interventional

Funder types

Other

Identifiers

NCT07039019

STUDY-25-00427

Details and patient eligibility

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Patients with Corticosteroids

Experimental group

Description:

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.

Treatment:

Drug: Corticosteroid

Patients with No Corticosteroids

Active Comparator group

Description:

Patients will not receive any corticosteroids.

Treatment:

Other: No Corticosteroid