Pleural Effusion Associated With Pulmonary InfectionCPENCT00468104
Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
A study testing Alteplase in people with Pleural Effusion Associated With Pulmonary Infection and Bacterial Pleural Effusion Other Than Tuberculosis, run by Midwest Pulmonary and Critical Care at 1 site in United States.
Trial summary
The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion Associated With Pulmonary Infection, Bacterial Pleural Effusion Other Than Tuberculosis
- What is being tested?
- Alteplase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Aug 2009
- Phase
- Interventional
- 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
- Diagnosed with complicated pleural effusions
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 18 years
Who cannot join
- Current use of oral anticoagulants (e.g., warfarin sodium) with an International Normalized Ratio (INR) >5- Activated partial thromboplastin time (aPPT) > 80, Platelet count < 100,000/mm3;
- Severe uncontrolled hypertension
- Recognized hypersensitivity to Activase; or any component of its formulation; Traumatic pleural effusion
- Pregnancy (positive pregnancy test)
- In another study for this condition
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Show all 13Show fewer
- Participation in another simultaneous medical investigation
- Recent stroke
- Intracranial hemorrhage
- arteriovenous malformation or aneurysm
- Intracranial neoplasm
- Acute myocardial infarction
- Acute pulmonary embolus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema
The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas
Read the detailed description
The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.
Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.
- Conditions
- Pleural Effusion Associated With Pulmonary Infection, Bacterial Pleural Effusion Other Than Tuberculosis
- Being tested
- Alteplase, Placebo
- Keywords
- parapneumonic pleural effusion, empyema, TPA (Activase, Alteplase)
- Medical subject headings
- Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days
PlaceboDrug
Also called TPA, Activase
Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days
| Study group | Role | What they receive |
|---|---|---|
| Alteplase, Placebo- intapleural instillation | Active comparator | Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted. Receives: Drug: Alteplase; Drug: Placebo |
| Placebo, Alteplase -2nd arm | Active comparator | If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days Receives: Drug: Alteplase; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Surgical Intervention
CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.
Measured: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months
Secondary outcomes (4)
Number of Participants With Pneumonia That Responded to Therapy
patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia
Measured: 6 weeks
Number of Participants With Pleural Effusion/Empyema That Responded to Therapy
patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema
Measured: 6 weeks
Number of Participants With Shortness of Breath That Responded to Therapy
patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented
Measured: 6 weeks
Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy
patients were followed for 6 weeks and resolution of sepsis was documented
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startApr 2004
- Primary completionOct 2008
- Study completionAug 2009
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 Effusion Associated With Pulmonary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Pulmonary and Critical Care
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, GEORGE THOMMI, Midwest Pulmonary and Critical Care
- Investigators
- George Thommi, MD, Principal investigator, Midwest Pulmonary and Critical Care, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468104
- Sponsor's protocol ID
- 11415
- Acronym
- CPE
- Status last verified
- Apr 2012
- First submitted
- 29 Apr 2007
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema
- ClinicalTrials.gov ID
- NCT00468104
- Acronym / sponsor ID
- CPE / 11415
- Conditions
- Pleural Effusion Associated With Pulmonary Infection, Bacterial Pleural Effusion Other Than Tuberculosis
- Keywords
- parapneumonic pleural effusion, empyema, TPA (Activase, Alteplase)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Midwest Pulmonary and Critical CareUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Posted 24 Apr 2012
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 study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas
Detailed description
The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.
Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase, Placebo- intapleural instillation | Active comparator | Drug: Alteplase, Drug: PlaceboEither 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted. |
| Placebo, Alteplase -2nd arm | Active comparator | Drug: Alteplase, Drug: PlaceboIf the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with complicated pleural effusions
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 18 years
Key exclusion criteria (13 listed)
- Current use of oral anticoagulants (e.g., warfarin sodium) with an International Normalized Ratio (INR) >5- Activated partial thromboplastin time (aPPT) > 80, Platelet count < 100,000/mm3;
- Severe uncontrolled hypertension
- Recognized hypersensitivity to Activase; or any component of its formulation; Traumatic pleural effusion
- Pregnancy (positive pregnancy test)
- In another study for this condition
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 |
|---|---|---|
| Alteplase25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days | Drug | Alteplase, Placebo- intapleural instillation, Placebo, Alteplase -2nd arm |
| PlaceboAlso: TPA, ActivasePlacebo in 100 cc of normal saline was instilled intrapleurally daily for three days | Drug | Alteplase, Placebo- intapleural instillation, Placebo, Alteplase -2nd arm |
Primary outcome
No Surgical Intervention
Time frame: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months
CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.
4 secondary outcomes
Number of Participants With Pneumonia That Responded to Therapy
Time frame: 6 weeks
Number of Participants With Pleural Effusion/Empyema That Responded to Therapy
Time frame: 6 weeks
Number of Participants With Shortness of Breath That Responded to Therapy
Time frame: 6 weeks
Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Thommi, MD principal investigator
Midwest Pulmonary and Critical Care, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alteplase in people with Pleural Effusion Associated With Pulmonary Infection and Bacterial Pleural Effusion Other Than Tuberculosis, run by Midwest Pulmonary and Critical Care 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 3 inclusion and 13 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 30 Apr 2012. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2012). 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?
No Surgical Intervention (time frame: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months). 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 30 Apr 2012.