NCT07039019 Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
| NCT ID | NCT07039019 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Pleuritis, Non-specific |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-05-29 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Udit Chaddha, MBBS
PRINCIPAL INVESTIGATOR
Icahn School of Medicine
Frequently Asked Questions
Who can join the NCT07039019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleuritis, Non-specific. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07039019 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07039019 currently recruiting?
Yes, NCT07039019 is actively recruiting participants. Contact the research team at axel.duval@mountsinai.org for enrollment information.
Where is the NCT07039019 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT07039019 clinical trial?
NCT07039019 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Udit Chaddha, MBBS at Icahn School of Medicine. The trial plans to enroll 40 participants.