Health TrialsbyHealthPanel

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

ConditionPleuritis, Non-specific
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Chronic/fibrinous pleuritis

Positive autoimmune serologic workup

A contraindication to corticosteroids

Empyema

Trial design

Design model

Parallel

Treatments tested in this trial

  • Corticosteroid

    Drug

    Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.

  • No Corticosteroid

    Other intervention

    Patients do not take corticosteroid.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patients with CorticosteroidsExperimental treatment 1 intervention
Group B: Patients with No CorticosteroidsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients screened

Screened defined as how many patients are evaluated for participation

Time frame
every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
2

Number of patients enrolled

Enrolled defined as how many screened patients actually join the study

Time frame
every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
3

Number of patients retained

Retention defined as how many enrolled patients continue participating over time

Time frame
every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months

Secondary outcomes

1

Rate of recurrence

Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention

Time frame
every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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