Corticosteroid
DrugPatients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.
Other names: Prednisone
NCT Number: NCT07039019
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Mount Sinai Hospital, New York, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.
Other names: Prednisone
Patients do not take corticosteroid.
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
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
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
Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention
Contact information is provided by the study sponsor or research team.
Icahn School of Medicine at Mount Sinai
Other
Pilot, RandOmized Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
Acronym: PROSPECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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