Pleural InfectionPhase 4NCT03468933
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
A Phase 4 study testing tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) and Medical Thoracoscopy in people with Pleural Infection and Empyema, run by Tulane University 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, Empyema, Pleural Diseases
- What is being tested?
- tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) and Medical Thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases
New Orleans, Louisiana, 70112
About this study
Official title: Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early 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 complicated 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: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients 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
Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
- Conditions
- Pleural Infection, Empyema, Pleural Diseases, Parapneumonic Effusion
- Being tested
- tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase), Medical Thoracoscopy
- Medical subject headings
- Empyema, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
Also called Pleuroscopy
Medical thoracoscopy will be performed as per standard protocols.
| Study group | Role | What they receive |
|---|---|---|
| Fibrinolytic therapy group | Active comparator | Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. Receives: Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) |
| Medical Thoracoscopy group | Active comparator | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Receives: Procedure: Medical Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Hospital Stay After Intervention
duration of hospital stay in days from time of procedure to discharge from hospital.
Measured: 12 week follow up period
Secondary outcomes (4)
Total Length of Hospital Stay
Total days spent in the hospital
Measured: 12 week follow up period
Number of Participants Necessitating Intervention After the Assigned Treatment
- Need for surgical intervention (VATS, Open Thoracotomy) in any arm
- Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure
- Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure
Measured: 12 week follow up period
Adverse Events
any Adverse events (pain, 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Nov 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pleural InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fayez Kheir,MD,MSc, Tulane University
- Investigators
- Fayez Kheir, MD, MSc, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468933
- Sponsor's protocol ID
- 1070390
- Status last verified
- Jan 2021
- First submitted
- 5 Mar 2018
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03468933
- Acronym / sponsor ID
- 1070390
- Conditions
- Pleural Infection, Empyema, Pleural Diseases, Parapneumonic Effusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 4 Feb 2021
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 complicated 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: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients 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
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 |
|---|---|---|
| Fibrinolytic therapy group | Active comparator | Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. |
| Medical Thoracoscopy group | Active comparator | Procedure: Medical ThoracoscopyPatients randomized to the Thoracoscopy group will undergo medical thoracoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Evidence of empyema or complex parapneumonic effusion
Key exclusion criteria (1 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 Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography
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 |
|---|---|---|
| tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)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 | Drug | Fibrinolytic therapy group |
| Medical ThoracoscopyAlso: PleuroscopyMedical thoracoscopy will be performed as per standard protocols. | Procedure or surgery | Medical Thoracoscopy group |
Primary outcome
Duration of Hospital Stay After Intervention
Time frame: 12 week follow up period
duration of hospital stay in days from time of procedure to discharge from hospital.
4 secondary outcomes
Total Length of Hospital Stay
Time frame: 12 week follow up period
Number of Participants Necessitating Intervention After the Assigned Treatment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pleural Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 4
VATS or Intrapleural Enzymatic Therapy for Patients With Empyema.
Empyema, Pleural, Pleural Infections
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Not yet recruiting
Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
Pleural Empyema
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.
Fayez Kheir, MD, MSc principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) and Medical Thoracoscopy in people with Pleural Infection and Empyema, run by Tulane University 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 1 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 4 Feb 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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 4 Feb 2021.