<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02973139</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000307</org_study_id>
    <nct_id>NCT02973139</nct_id>
  </id_info>
  <brief_title>Fibrinolysis Compared to Thoracoscopy for Pleural Infection</brief_title>
  <official_title>Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective randomized clinical trial is to compare two currently&#xD;
      accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to&#xD;
      instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant&#xD;
      Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion&#xD;
      (CPPE) in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents&#xD;
      one of the most common clinical diagnoses encountered in clinical practice in the United&#xD;
      States (US) It is associated with substantial morbidity and mortality despite advances in&#xD;
      medical diagnostic and therapeutic strategies.&#xD;
&#xD;
      Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy&#xD;
&#xD;
      Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total&#xD;
      of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic&#xD;
      Therapy group.&#xD;
&#xD;
      Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient&#xD;
      setting&#xD;
&#xD;
      Primary Outcome: Duration of hospital stay after intervention&#xD;
&#xD;
      Secondary Outcome: Failure rate of assigned treatment and adverse events&#xD;
&#xD;
      Potential Outcome and Benefit: Determine best strategy for treating patients with pleural&#xD;
      infection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of hospital stay after intervention</measure>
    <time_frame>12 week follow up period</time_frame>
    <description>Number of days hospitalized</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days with chest drainage</measure>
    <time_frame>12 week follow up period</time_frame>
    <description>Number of days with chest drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total length of hospital stay</measure>
    <time_frame>12 week follow up period</time_frame>
    <description>Total days spent in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure rate of assigned treatment necessitating intervention</measure>
    <time_frame>12 week follow up period</time_frame>
    <description>defined as any of the following:&#xD;
Surgical intervention (VATS, open thoracotomy) in the medical thoracoscopy or fibrinolytic therapy arm&#xD;
Need of additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to clinical non-responsiveness&#xD;
Need of additional chest tube in the fibrinolytic therapy arm due to clinical non-responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 week follow up period</time_frame>
    <description>Any adverse event (pain or bleeding)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital and 30-day mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death of a patient while being hospitalized or up to 30 days after</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software</measure>
    <time_frame>12 week follow up period</time_frame>
    <description>Pleural fluid volume measured with CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively</measure>
    <time_frame>at randomization and at 6 and12 week follow up visit</time_frame>
    <description>Inflammatory biomarker measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total costs of each treatment modality</measure>
    <time_frame>6 and 12 week follow up period</time_frame>
    <description>Total cost of each of treatment modality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Pleural Infection</condition>
  <condition>Pleural Diseases</condition>
  <arm_group>
    <arm_group_label>Thoracoscopy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibrinolytic group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Thoracoscopy</intervention_name>
    <description>Medical thoracoscopy will be performed as per standard protocols.</description>
    <arm_group_label>Thoracoscopy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fibrinolytic Group</intervention_name>
    <description>Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses</description>
    <arm_group_label>Fibrinolytic group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects &gt;18 years old with:&#xD;
&#xD;
          -  Evidence of empyema or complex parapneumonic effusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to give informed written consent&#xD;
&#xD;
          -  Previous thoracic surgery or thrombolytic therapy for pleural infection&#xD;
&#xD;
          -  Medical thoracoscopy cannot be performed within 48 hours&#xD;
&#xD;
          -  Hemodynamic instability or severe hypoxemia&#xD;
&#xD;
          -  Non corrected coagulopathy&#xD;
&#xD;
          -  Homogeneously echogenic effusion on pleural ultrasonography&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>December 24, 2019</last_update_submitted>
  <last_update_submitted_qc>December 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Adnan Majid</investigator_full_name>
    <investigator_title>MD FCCP</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Pleural Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02973139
org study id: 2016P000307
nct id: NCT02973139
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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 complex parapneumonic effusion
      (CPPE) in adults.
Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents
      one of the most common clinical diagnoses encountered in clinical practice in the United
      States (US) It is associated with substantial morbidity and mortality despite advances in
      medical diagnostic and therapeutic strategies.

      Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy

      Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total
      of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic
      Therapy group.

      Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient
      setting

      Primary Outcome: Duration of hospital stay after intervention

      Secondary Outcome: Failure rate of assigned treatment and adverse events

      Potential Outcome and Benefit: Determine best strategy for treating patients with pleural
      infection
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of hospital stay after intervention
time frame: 12 week follow up period
description: Number of days hospitalized
measure: Number of days with chest drainage
time frame: 12 week follow up period
description: Number of days with chest drainage
measure: Total length of hospital stay
time frame: 12 week follow up period
description: Total days spent in the hospital
measure: Failure rate of assigned treatment necessitating intervention
time frame: 12 week follow up period
description: defined as any of the following:
Surgical intervention (VATS, open thoracotomy) in the medical thoracoscopy or fibrinolytic therapy arm
Need of additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to clinical non-responsiveness
Need of additional chest tube in the fibrinolytic therapy arm due to clinical non-responsiveness
measure: Adverse events
time frame: 12 week follow up period
description: Any adverse event (pain or bleeding)
measure: In hospital and 30-day mortality
time frame: 30 days
description: Death of a patient while being hospitalized or up to 30 days after
measure: Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software
time frame: 12 week follow up period
description: Pleural fluid volume measured with CT scan
measure: Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively
time frame: at randomization and at 6 and12 week follow up visit
description: Inflammatory biomarker measure
measure: Total costs of each treatment modality
time frame: 6 and 12 week follow up period
description: Total cost of each of treatment modality
arm group label: Thoracoscopy group
arm group type: Active Comparator
description: Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
arm group label: Fibrinolytic group
arm group type: Active Comparator
description: Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
intervention type: Other
intervention name: Medical Thoracoscopy
description: Medical thoracoscopy will be performed as per standard protocols.
arm group label: Thoracoscopy group
intervention type: Other
intervention name: Fibrinolytic Group
description: Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses
arm group label: Fibrinolytic group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Adnan Majid
investigator title: MD FCCP
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pleural Diseases
sharing ipd: No