NCT02973139

Brief 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 complex parapneumonic effusion (CPPE) in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

November 22, 2016

Last Update Submit

December 24, 2019

Conditions

Pleural InfectionPleural Diseases

Outcome Measures

Primary Outcomes (1)

  • Duration of hospital stay after intervention

    Number of days hospitalized

    12 week follow up period

Secondary Outcomes (8)

  • Number of days with chest drainage

    12 week follow up period

  • Total length of hospital stay

    12 week follow up period

  • Failure rate of assigned treatment necessitating intervention

    12 week follow up period

  • Adverse events

    12 week follow up period

  • In hospital and 30-day mortality

    30 days

  • +3 more secondary outcomes

Study Arms (2)

Thoracoscopy group

ACTIVE COMPARATOR

Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Other: Medical Thoracoscopy

Fibrinolytic group

ACTIVE COMPARATOR

Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)

Other: Fibrinolytic Group

Interventions

Medical ThoracoscopyOTHER

Medical thoracoscopy will be performed as per standard protocols.

Thoracoscopy group
Fibrinolytic GroupOTHER

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

Fibrinolytic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects \>18 years old with:
  • Evidence of empyema or complex parapneumonic effusion

You may not qualify if:

  • Age \<18 years
  • Pregnancy
  • Inability to give informed written consent
  • Previous thoracic surgery or thrombolytic therapy for pleural infection
  • Medical thoracoscopy cannot be performed within 48 hours
  • Hemodynamic instability or severe hypoxemia
  • Non corrected coagulopathy
  • Homogeneously echogenic effusion on pleural ultrasonography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Kheir F, Thakore S, Mehta H, Jantz M, Parikh M, Chee A, Kaphle U, Sisnega C, Fernandez-Bussy S, Majid A. Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial. Ann Am Thorac Soc. 2020 Aug;17(8):958-964. doi: 10.1513/AnnalsATS.202001-076OC.

    PMID: 32421353DERIVED

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD FCCP

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

July 14, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

December 26, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)