Pleural InfectionNCT02973139
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
A study testing Medical Thoracoscopy and Fibrinolytic Group in people with Pleural Infection and Pleural Diseases, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Infection, Pleural Diseases
- What is being tested?
- Medical Thoracoscopy and Fibrinolytic Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects >18 years old with:
- Evidence of empyema or complex parapneumonic effusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
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.
Read the detailed description
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
- Conditions
- Pleural Infection, Pleural Diseases
- Being tested
- Medical Thoracoscopy, Fibrinolytic Group
- Medical subject headings
- Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ThoracoscopyOther
Medical thoracoscopy will be performed as per standard protocols.
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
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopy group | Active comparator | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Receives: 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) Receives: Other: Fibrinolytic Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay after intervention
Number of days hospitalized
Measured: 12 week follow up period
Secondary outcomes (8)
Number of days with chest drainage
Number of days with chest drainage
Measured: 12 week follow up period
Total length of hospital stay
Total days spent in the hospital
Measured: 12 week follow up period
Failure rate of assigned treatment necessitating intervention
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
Measured: 12 week follow up period
Adverse events
Any adverse event (pain or bleeding)
Measured: 12 week follow up period
In hospital and 30-day mortality
Death of a patient while being hospitalized or up to 30 days after
Measured: 30 days
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
Pleural fluid volume measured with CT scan
Measured: 12 week follow up period
Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively
Inflammatory biomarker measure
Measured: at randomization and at 6 and12 week follow up visit
Total costs of each treatment modality
Total cost of each of treatment modality
Measured: 6 and 12 week follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start14 Jul 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural InfectionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Majid, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973139
- Sponsor's protocol ID
- 2016P000307
- Status last verified
- Dec 2019
- First submitted
- 22 Nov 2016
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32421353
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02973139
- Acronym / sponsor ID
- 2016P000307
- Conditions
- Pleural Infection, Pleural Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopy group | Active comparator | Other: Medical ThoracoscopyPatients randomized to the Thoracoscopy group will undergo medical thoracoscopy. |
| Fibrinolytic group | Active comparator | Other: Fibrinolytic GroupPatients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects >18 years old with:
- Evidence of empyema or complex parapneumonic effusion
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical ThoracoscopyMedical thoracoscopy will be performed as per standard protocols. | Other | Thoracoscopy group |
| Fibrinolytic GroupPatients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses | Other | Fibrinolytic group |
Primary outcome
Duration of hospital stay after intervention
Time frame: 12 week follow up period
Number of days hospitalized
8 secondary outcomes
Number of days with chest drainage
Time frame: 12 week follow up period
Total length of hospital stay
Time frame: 12 week follow up period
Failure rate of assigned treatment necessitating intervention
Time frame: 12 week follow up period
Adverse events
Time frame: 12 week follow up period
In hospital and 30-day mortality
Time frame: 30 days
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
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
Total costs of each treatment modality
Time frame: 6 and 12 week follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 32421353Kheir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Thoracoscopy and Fibrinolytic Group in people with Pleural Infection and Pleural Diseases, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay after intervention (time frame: 12 week follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.