Empyema, PleuralPhase 4NCT03873766
Management of Pleural Space Infections
A Phase 4 study testing Intrapleural Medications, Surgery and Pleural Sampling in people with Empyema, Pleural and Parapneumonic Effusion, run by Swedish Medical Center at 1 site in United States.
Trial summary
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Empyema, Pleural, Parapneumonic Effusion
- What is being tested?
- Intrapleural Medications, Surgery and Pleural Sampling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 11 Mar 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Clinical presentation compatible with pleural infection (fever or leukocytosis, elevated procalcitonin, elevated C-reactive protein (CRP))
- Pleural fluid requiring drainage that is either:
- Macroscopically purulent or
- Positive on culture for bacterial infection or
- Positive for bacteria on gram stain or
- Lactate dehydrogenase (LDH) > 1000 IU/L or
- Glucose <40 mg/dL
Who cannot join
- Age <18 years
- Unable to give consent (No surrogate consent of legally authorized representatives allowed for this study)
- Not proficient in English
- History of prior ipsilateral empyema
- Has known sensitivity to DNase or alteplase
- History of intracranial hemorrhage or acute intracranial hemorrhage
Show all 16Show fewer
- History of stroke, hemorrhage, or trauma within the last 3 months
- Has had prior surgery on the side of the pleural infection
- Patients who are pregnant or lactating
- Expected survival less than 6 months from a different pathology to this pleural infection based on clinical judgment
- Has a tunneled pleural catheter in place
- Patients on anticoagulation that cannot be interrupted for surgical intervention
- Patients with known or suspected malignant pleural effusion
- Patients with renal failure (Creatinine clearance <30)
- Prior history of or concern for chylothorax or pseudochylothorax
- Vulnerable populations: prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.
This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.
Read the detailed description
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.
This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.
Patient's with complex pleural space infections identified at the institution that meet inclusion criteria will be randomized to receive either IPFT or surgical debridement after a surgery consultation is obtained. Patients randomized to the IPFT study arm will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg BID x 3 days delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. If the first IPFT dose is given in the evening on the first day, they will only receive a total of 5 doses of the dual-agent IPFT (alteplase and DNase). The surgical arm will have either open surgery of a VATS approach at the discretion of the surgeon.
IPFT (alteplase and DNase) is not an investigational agent. It is used in standard of care practice for the treatment of complex pleural space infections. The investigators seek to compare dual-agent IPFT (alteplase and DNase) to surgery in this study. As such, the IPFT agents will be ordered from pharmacy through the electronic medical record (EMR) as in normal practice and there is not a study drug.
After drainage, patients will be followed with protocol images to assess the drainage of their pleural space. If there is satisfactory improvement in the pleural fluid collection on imaging chest tube or small bore catheter will be removed per protocol in both study arms. Chest tube removal protocol is based on fluid character and measured output.
- Conditions
- Empyema, Pleural, Parapneumonic Effusion
- Being tested
- Intrapleural Medications, Surgery, Pleural Sampling, Pleural fluid drainage, Protocol Image #1
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapleural MedicationsDrug
Also called IPFT
The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. If the first IPFT dose is given in the evening on the first day, they will only receive a total of 5 doses of the dual-agent IPFT (alteplase and DNase).
SurgeryProcedure or surgery
The surgical arm will have either open surgery or a Video assisted Thoracoscopic Surgery (VATS) approach at the discretion of the surgeon
Pleural SamplingProcedure or surgery
Pleural fluid may be sampled by the responsible clinical service in the course of clinical care for patients with suspected pulmonary infection or by consulting service after identification of patient. Some patients will have a thoracentesis or tube drainage, and others will have no intervention at the time of referral for study eligibility review. Enrollment reflects real world clinical care and patients will be considered for enrollment regardless of sampling techniques or timing prior to evaluation
Pleural fluid drainageProcedure or surgery
All patients in the study must have tube thoracostomy for drainage of the pleural space. This may have been done by the clinically responsible team or by the study team. Physicians may select chest tubes of any type, but the minimum size is 14 French. For patency, chest tubes 14-20 French should be kept at negative 20 suction and flushed daily. Large bore chest tubes (>20French) may be kept at negative 20 suction at the discretion of the physician managing the chest tube and do not require daily flushing. Supportive care will follow Institutional Guidelines.
Protocol Image #1Radiation
Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. The choice of image, either Chest X-ray or CT Chest, is up to the discretion of the treating physician. Based on the imaging, patients will be separated into 2 groups:
A: Complete drainage/re-expansion of the lung: If there is complete drainage of the pleural fluid collection and lung re-expansion based on image #1, patients will follow usual clinical care without randomization and be observed until discharge. Patients will remain in the study and their data will be collected.
B: Incomplete drainage/incomplete lung re-expansion: For those patients that have incomplete drainage of the pleural fluid collection on image #1 and/or the lung does not re-expand.
Surgical ConsultationOther
A thoracic surgery consultation will be obtained on all patients with incomplete drainage and/or the lung does not re-expand, to determine surgical candidacy. Those patients that the surgical team deem unsafe for surgery will receive clinically appropriate guideline centered, non-surgical, care. These patients will not be randomized but they will remain in the study and their data will be collected. Criteria deeming patients unfit for surgery include, but are not limited to: inability to tolerate single lung ventilation, severe chronic obstructive pulmonary disease (COPD), and risk of surgery prohibitive. Patients not excluded from surgery will be randomized.
Protocol Image #2: Chest X-ray PA/LateralRadiation
The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained (protocol image #2). Based on Image #2 the patient will be categorized into one of three groups: satisfactory improvement of pleural fluid collection, unsatisfactory improvement in pleural fluid collection on imaging, or treatment failures.
Quality of LifeBehavioural
Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Intrapleural fibrinolytic therapy (IPFT) | Active comparator | * Procedure/Surgery: Pleural Sampling
* Procedure/Surgery: Pleural fluid drainage
* Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
* Other: Surgical Consultation
* Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day.
* Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained
* Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires Receives: Drug: Intrapleural Medications; Procedure: Pleural Sampling; Procedure: Pleural fluid drainage; Radiation: Protocol Image #1; Other: Surgical Consultation; Radiation: Protocol Image #2: Chest X-ray PA/Lateral; Behavioral: Quality of Life |
| Surgery | Active comparator | * Procedure/Surgery: Pleural Sampling
* Procedure/Surgery: Pleural fluid drainage: Chest tube placement
* Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage.
* Other: Surgical Consultation
* Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon
* Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained
* Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires Receives: Procedure: Surgery; Procedure: Pleural Sampling; Procedure: Pleural fluid drainage; Radiation: Protocol Image #1; Other: Surgical Consultation; Radiation: Protocol Image #2: Chest X-ray PA/Lateral; Behavioral: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the proposed study algorithm as measured by percent of subjects enrolled to study completion, percent of subjects randomized but did not complete the study, and percent of health care professional protocol deviation
- Test the feasibility of the proposed study algorithm to compare Intrapleural fibrinolytic therapy (IPFT) to surgical intervention as measured by percent enrollment to completion of study algorithm and multidisciplinary participation in adherence to the algorithm.
Measured: From patient identification to 1 year post discharge
Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year
Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year
Measured: From patient identification to 1 year post discharge
Secondary outcomes (6)
Radiographic improvement
Imaging will be posterior-anterior (PA) and lateral chest x-ray to determine radiographic change. Images will be saved and exported as JPEG files and opened in image editing software. Polygons will be drawn representing fluid collections and the hemithorax area covered will be calculated with the volume derived.
Change in fluid volume will be quantified as:
- Less than 50%
- Between 50-75%
- Greater than 75% Change of greater than 75% will be considered satisfactory improvement. Chest radiograph images will be reviewed and measured by two independent radiologists. If greater than 5% discrepancy in fluid volume change is reported, the independent radiologists will re-read and re-measure the images together.
Measured: From date of protocol Image #1 (once the chest tube is placed, protocol image #1 is obtained within 24-48 hours) to date of protocol Image #2 (the morning after intervention, approximately 12-24 hours after intervention)
Number of participants who have treatment failures needing further treatment crossover (IPFT to surgery; surgery to IPFT)
Treatment failures are defined as any patients with evidence of ongoing infection, persistently undrained pleural space and fever or elevated inflammatory markers still present at least 48 hours after completion of their intervention. Treatment failures will be treated at the discretion of the clinically responsible team, this may include but is not limited to study arm crossover. If a patient is a treatment failure and has treatment crossover (IPFT to surgery, surgery to IPFT), the data will documented with the data collection.
Measured: From patient identification to 1 year post discharge
Number of participants with procedure related complications
Documented using the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From intervention with IPFT or surgery to date of discharge from hospital, usually 7-10 days
Quality of life Surveys: 36-Item Short Form Survey (SF-36)
Quality of life will be measured at 30 day and 90 day clinical follow-up using the SF-36 quality of life survey. The SF-36 is a 36 question survey that assesses survey general health on a scale of 1-5 (1=excellent, 5=poor). In addition it assesses how current health limits activities such as walking, daily activities of bathing and dressing oneself. A higher score defines a more favorable health state. Each item is score on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Secondarily, the scores to each question are averaged in the groups in which they are categorized to create an 8 scale scores. The 8 scale categories are: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
Measured: Quality of life will be measured at 30 day and 90 day clinical follow-up
Cost comparison
Cost Comparison: As one of the secondary endpoints for the study, we will perform a cost comparison between the two study arms (IPFT and surgical drainage). Cost data will be obtained from billing data from the patient's hospital admission for stay and procedures related to the patients complicated pleural space infection. No billing data will be obtained directly from the participants in the study.
Measured: From date of intervention with IPFT or surgery to date of discharge from hospital, usually 7-10 days
Chest tube duration
The length of time the chest tube is in the patient. The study algorithm governs chest tube removal parameters: Once it has been deemed that there is satisfactory improvement in imaging and no signs of ongoing infection, the chest tube will be removed per protocol. Criteria for removal: Fluid non purulent, serous in character, pleural drain output is less than 200 cc/24 hours
Measured: From date of initiation of intervention of IPFT or surgery (approximately 24-48 hours after patient identification) to date of removal of chest tube, approximately 7 days after placement depending on the intervention and the chest tube output.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2019
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
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 Empyema, PleuralStudies 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
- Model description
- Patients will be randomized to either IPFT or surgery for treatment of their complex pleural space infection
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jed Gorden, MD, Principal investigator, Swedish Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873766
- Sponsor's protocol ID
- STUDY2018000278
- Status last verified
- Nov 2022
- First submitted
- 2 Oct 2018
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilshire CL, Jackson AS, Vallieres E, Bograd AJ, Louie BE, Aye RW, Farivar AS, White PT, Gilbert CR, Gorden JA. Effect of Intrapleural Fibrinolytic Therapy vs Surgery for Complicated Pleural Infections: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237799. doi: 10.1001/jamanetworkopen.2023.7799.
PubMed 37043201
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pleural Space Infections
- ClinicalTrials.gov ID
- NCT03873766
- Acronym / sponsor ID
- STUDY2018000278
- Conditions
- Empyema, Pleural, Parapneumonic Effusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- 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.
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.
This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.
Detailed description
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.
This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.
Patient's with complex pleural space infections identified at the institution that meet inclusion criteria will be randomized to receive either IPFT or surgical debridement after a surgery consultation is obtained. Patients randomized to the IPFT study arm will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg BID x 3 days delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. If the first IPFT dose is given in the evening on the first day, they will only receive a total of 5 doses of the dual-agent IPFT (alteplase and DNase). The surgical arm will have either open surgery of a VATS approach at the discretion of the surgeon.
IPFT (alteplase and DNase) is not an investigational agent. It is used in standard of care practice for the treatment of complex pleural space infections. The investigators seek to compare dual-agent IPFT (alteplase and DNase) to surgery in this study. As such, the IPFT agents will be ordered from pharmacy through the electronic medical record (EMR) as in normal practice and there is not a study drug.
After drainage, patients will be followed with protocol images to assess the drainage of their pleural space. If there is satisfactory improvement in the pleural fluid collection on imaging chest tube or small bore catheter will be removed per protocol in both study arms. Chest tube removal protocol is based on fluid character and measured output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either IPFT or surgery for treatment of their complex pleural space infection
| Arm | Type | Receives |
|---|---|---|
| Intrapleural fibrinolytic therapy (IPFT) | Active comparator | Drug: Intrapleural Medications, Procedure: Pleural Sampling, Procedure: Pleural fluid drainage, Radiation: Protocol Image #1, Other: Surgical Consultation, Radiation: Protocol Image #2: Chest X-ray PA/Lateral, Behavioral: Quality of Life* Procedure/Surgery: Pleural Sampling * Procedure/Surgery: Pleural fluid drainage * Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. * Other: Surgical Consultation * Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. * Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained * Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires |
| Surgery | Active comparator | Procedure: Surgery, Procedure: Pleural Sampling, Procedure: Pleural fluid drainage, Radiation: Protocol Image #1, Other: Surgical Consultation, Radiation: Protocol Image #2: Chest X-ray PA/Lateral, Behavioral: Quality of Life* Procedure/Surgery: Pleural Sampling * Procedure/Surgery: Pleural fluid drainage: Chest tube placement * Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. * Other: Surgical Consultation * Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon * Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained * Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Clinical presentation compatible with pleural infection (fever or leukocytosis, elevated procalcitonin, elevated C-reactive protein (CRP))
- Pleural fluid requiring drainage that is either:
Key exclusion criteria (16 listed)
- Age <18 years
- Unable to give consent (No surrogate consent of legally authorized representatives allowed for this study)
- Not proficient in English
- History of prior ipsilateral empyema
- Has known sensitivity to DNase or alteplase
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 |
|---|---|---|
| Intrapleural MedicationsAlso: IPFTThe IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. If the first IPFT dose is given in the evening on the first day, they will only receive a total of 5 doses of the dual-agent IPFT (alteplase and DNase). | Drug | Intrapleural fibrinolytic therapy (IPFT) |
| SurgeryThe surgical arm will have either open surgery or a Video assisted Thoracoscopic Surgery (VATS) approach at the discretion of the surgeon | Procedure or surgery | Surgery |
| Pleural SamplingPleural fluid may be sampled by the responsible clinical service in the course of clinical care for patients with suspected pulmonary infection or by consulting service after identification of patient. Some patients will have a thoracentesis or tube drainage, and others will have no intervention at the time of referral for study eligibility review. Enrollment reflects real world clinical care and patients will be considered for enrollment regardless of sampling techniques or timing prior to evaluation | Procedure or surgery | Intrapleural fibrinolytic therapy (IPFT), Surgery |
| Pleural fluid drainageAll patients in the study must have tube thoracostomy for drainage of the pleural space. This may have been done by the clinically responsible team or by the study team. Physicians may select chest tubes of any type, but the minimum size is 14 French. For patency, chest tubes 14-20 French should be kept at negative 20 suction and flushed daily. Large bore chest tubes (>20French) may be kept at negative 20 suction at the discretion of the physician managing the chest tube and do not require daily flushing. Supportive care will follow Institutional Guidelines. | Procedure or surgery | Intrapleural fibrinolytic therapy (IPFT), Surgery |
| Protocol Image #1Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. The choice of image, either Chest X-ray or CT Chest, is up to the discretion of the treating physician. Based on the imaging, patients will be separated into 2 groups: A: Complete drainage/re-expansion of the lung: If there is complete drainage of the pleural fluid collection and lung re-expansion based on image #1, patients will follow usual clinical care without randomization and be observed until discharge. Patients will remain in the study and their data will be collected. B: Incomplete drainage/incomplete lung re-expansion: For those patients that have incomplete drainage of the pleural fluid collection on image #1 and/or the lung does not re-expand. | Radiation | Intrapleural fibrinolytic therapy (IPFT), Surgery |
| Surgical ConsultationA thoracic surgery consultation will be obtained on all patients with incomplete drainage and/or the lung does not re-expand, to determine surgical candidacy. Those patients that the surgical team deem unsafe for surgery will receive clinically appropriate guideline centered, non-surgical, care. These patients will not be randomized but they will remain in the study and their data will be collected. Criteria deeming patients unfit for surgery include, but are not limited to: inability to tolerate single lung ventilation, severe chronic obstructive pulmonary disease (COPD), and risk of surgery prohibitive. Patients not excluded from surgery will be randomized. | Other | Intrapleural fibrinolytic therapy (IPFT), Surgery |
| Protocol Image #2: Chest X-ray PA/LateralThe morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained (protocol image #2). Based on Image #2 the patient will be categorized into one of three groups: satisfactory improvement of pleural fluid collection, unsatisfactory improvement in pleural fluid collection on imaging, or treatment failures. | Radiation | Intrapleural fibrinolytic therapy (IPFT), Surgery |
| Quality of LifeQuality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires | Behavioural | Intrapleural fibrinolytic therapy (IPFT), Surgery |
Primary outcome
Feasibility of the proposed study algorithm as measured by percent of subjects enrolled to study completion, percent of subjects randomized but did not complete the study, and percent of health care professional protocol deviation
Time frame: From patient identification to 1 year post discharge
• Test the feasibility of the proposed study algorithm to compare Intrapleural fibrinolytic therapy (IPFT) to surgical intervention as measured by percent enrollment to completion of study algorithm and multidisciplinary participation in adherence to the algorithm.
Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year
Time frame: From patient identification to 1 year post discharge
Subject identification and accrual as measured by the percent of patients not screened and randomized and the time to accrual of 20 patients of the number of patients accrued in one year
6 secondary outcomes
Radiographic improvement
Time frame: From date of protocol Image #1 (once the chest tube is placed, protocol image #1 is obtained within 24-48 hours) to date of protocol Image #2 (the morning after intervention, approximately 12-24 hours after intervention)
Number of participants who have treatment failures needing further treatment crossover (IPFT to surgery; surgery to IPFT)
Time frame: From patient identification to 1 year post discharge
Number of participants with procedure related complications
Time frame: From intervention with IPFT or surgery to date of discharge from hospital, usually 7-10 days
Quality of life Surveys: 36-Item Short Form Survey (SF-36)
Time frame: Quality of life will be measured at 30 day and 90 day clinical follow-up
Cost comparison
Time frame: From date of intervention with IPFT or surgery to date of discharge from hospital, usually 7-10 days
Chest tube duration
Time frame: From date of initiation of intervention of IPFT or surgery (approximately 24-48 hours after patient identification) to date of removal of chest tube, approximately 7 days after placement depending on the intervention and the chest tube output.
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 22 Nov 2022.
- Derived from this study: PubMed 37043201Wilshire CL, Jackson AS, Vallieres E, Bograd AJ, Louie BE, Aye RW, Farivar AS, White PT, Gilbert CR, Gorden JA. Effect of Intrapleural Fibrinolytic Therapy vs Surgery for Complicated Pleural Infections: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237799. doi: 10.1001/jamanetworkopen.2023.7799.
- 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.
Jed Gorden, MD principal investigator
Swedish Cancer Institute
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 Intrapleural Medications, Surgery and Pleural Sampling in people with Empyema, Pleural and Parapneumonic Effusion, run by Swedish 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 8 inclusion and 16 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 22 Nov 2022. 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?
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?
Feasibility of the proposed study algorithm as measured by percent of subjects enrolled to study completion, percent of subjects randomized but did not complete the study, and percent of health care professional protocol deviation (time frame: From patient identification to 1 year post discharge). The study lists 2 primary outcomes in all. 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 NCT03873766, 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 22 Nov 2022.