A Phase 4 interventional study of Chest thoracoscopy and Chest fibrinolytic therapy in Pleural Diseases, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
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 complicated pleural infections in adults as defined as complicated parapneumonic effusions or pleural empyema.
Pleural infection (empyema or complex parapneumonic effusion [CPPE]) represents one of the common clinical diagnoses encountered in clinical practice in the United States (US) and worldwide. The incidence of pleural infection continues to rise with an annual incidence of approximately 65,000 in the US and United Kingdom (UK). It is associated with substantial morbidity and mortality as well as increased hospital costs despite advances in medical diagnostic and therapeutic strategies. The overall mortality of pleural infection approaches 20% and it is above 30% in elderly patients over 65 years and immunocompromised patients.
Treatment of CPPE or empyema requires antibiotics and drainage of the pleural cavity.3 However, in about 30% of cases, it is difficult to remove the fluid due to loculations, septations and increased viscosity of the pleural fluid, and around 20% will need surgical intervention to adequately treat the pleural infection.
Specific Aim 1:
To compare the efficacy of early medical thoracoscopy versus fibrinolytic therapy (tPA/DNase) in patients with complicated parapneumonic effusions or pleural empyema.
CPPE is defined as non-purulent effusion in a patient with clinical evidence of infection such as fever and/or elevated blood leukocyte count and/or elevated CRP, with pleural fluid pH ≤ 7.2 (measured by blood-gas analyzer), or pleural fluid glucose \< 60 mg/dl or pleural fluid LDH >1000 IU/L26. Empyema is defined as pus within the pleural space and/or presence of bacteria on pleural fluid Gram stain or culture.
For patients to be considered for the trial they need to fulfill one of the following criteria: 1) CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan or 2) empyema.
49 studies on the registry are indexed under Pleural Diseases; 13 are open to participants now.
This study's enrollment of 5 is below the median of 91 across 34 interventional studies indexed under Pleural Diseases.
Browse Pleural Diseases studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
Consisting of chest thoracoscopy
Procedure: Chest thoracoscopy
Consisting of chest fibrinolytic therapy
Procedure: Chest fibrinolytic therapy · Drug: tPA · Drug: DNase
Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
Also known as: Actilyse
DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
Also known as: pulmozyme
Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.
Time between initiation of treatment and hospital discharge
Time frame: 30 days starting on day of admission
Duration of Chest Tube
The number of days, during the hospital admission, where the patient demonstrated chest tube drainage
Time frame: 30 days starting on day of admission
Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection
Number of days patient registered as in-house for treatment of pleural infection
Time frame: 30 days starting on day of admission
Treatment Failure
Following intervention, if patient requires (1) surgical intervention (VATS, open thoracotomy), (2) an additional chest tube, or (3) a repeat procedure
Time frame: 30 days starting on day of admission
Number of Participants With Adverse Events
Number of participants who experienced documented adverse events during their hospital stays
Time frame: 30 days starting on day of admission
Mortality
In hospital and 30 day mortality measures
Time frame: 30 days starting on day of admission
The study participants comprised a convenience sample of adults with CPPE or empyema who presented to the UFHealth pulmonary medicine service, met all inclusion / exclusion criteria, and agreed to participate.
| Milestone | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
Time between initiation of treatment and hospital discharge
| days | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema. | 13 (7 to 16) | 18.5 (15 to 22) |
The number of days, during the hospital admission, where the patient demonstrated chest tube drainage
| days | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Duration of Chest Tube | 13 (6 to 13) | 7 (6 to 8) |
Number of days patient registered as in-house for treatment of pleural infection
| days | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection | 13 (7 to 16) | 18.5 (15 to 22) |
Following intervention, if patient requires (1) surgical intervention (VATS, open thoracotomy), (2) an additional chest tube, or (3) a repeat procedure
| Participants | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Treatment Failure | 2 | 1 |
Number of participants who experienced documented adverse events during their hospital stays
| Participants | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Number of Participants With Adverse Events | 0 | 0 |
In hospital and 30 day mortality measures
| Participants | Thoracoscopy Arm | Fibrinolytic Therapy Arm |
|---|---|---|
| Mortality | 0 | 0 |
Collected over Adverse event data was collected starting at consent, and up to 12 weeks post-procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Thoracoscopy Arm | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Fibrinolytic Therapy Arm | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Thoracoscopy Arm | Fibrinolytic Therapy Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Thoracoscopy Arm | Fibrinolytic Therapy Arm | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 1 | 0 | 1 |
| Race and Ethnicity Not Collected(Participants) | Thoracoscopy Arm | Fibrinolytic Therapy Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Thoracoscopy Arm | Fibrinolytic Therapy Arm | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
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