CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) +1 moredrug
Likely dose
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03468933
NCT03468933Phase 4Completed
CompareCT.gov

Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial

Tulane University·interventional·Posted Mar 19, 2018·Updated Feb 4, 2021

In Brief

A Phase 4 clinical trial evaluating tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) and Medical Thoracoscopy for Pleural Infection and 3 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPleural Infection, Empyema, Pleural Diseases, Parapneumonic Effusion
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartNov 1, 2017
Primary CompletionDec 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.3 years ago

Interventions

tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)drug

Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose

Medical Thoracoscopyprocedure

Medical thoracoscopy will be performed as per standard protocols.