EmpyemaNCT00103766
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
A study testing Alteplase in people with Empyema and Pleural Effusion, run by O'Brien, Jeana D., MD, FACP, FCCP at 1 site in United States.
Trial summary
The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empyema, Pleural Effusion
- What is being tested?
- Alteplase
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to not given
- 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
- Ability to provide written informed consent
- Age greater or equal to 18 yrs
- Presence of empyema or CPE
Who cannot join
- Active internal bleeding
- Pregnancy
- Prior enrollment in this study
- Platelet count less than 100,000/mm3
- Use of warfarin sodium if INR is greater than 1.7
- Use of heparin unless the PTT is less than 1.5 times baseline normal
Show all 9Show fewer
- Known neurological disorders
- Current or pre-existing bleeding dyscrasia
- Known allergy to Alteplase
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scott and White Memorial Hospital & Clinic
Temple, Texas, 76508
Delores Gautier, RN, MSN, 254-724-1769, lgautier@swmail.sw.org
Jeana D O'Brien, MD, FACP, FCCP
About this study
Official title: Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.
Read the detailed description
This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.
- Conditions
- Empyema, Pleural Effusion
- Being tested
- Alteplase
- Keywords
- Alteplase, Empyema, Complicated Parapneumonic Effusion
- Medical subject headings
- Empyema, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
Secondary outcomes (4)
Mortality
Hospital length of stay
Daily chest tube drainage
Radiographic improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2005 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpyemaStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- O'Brien, Jeana D., MD, FACP, FCCP
- Collaborators
- Genentech, Inc., Scott and White Hospital & Clinic, Scott, Sherwood and Brindley Foundation, Texas A&M University
- Investigators
- Jeana D O'Brien, MD, FACP, FCCP, Principal investigator, Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103766
- Sponsor's protocol ID
- 8736
- Status last verified
- Jul 2006
- First submitted
- 14 Feb 2005
- Last updated
- 1 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
- ClinicalTrials.gov ID
- NCT00103766
- Acronym / sponsor ID
- 8736
- Conditions
- Empyema, Pleural Effusion
- Keywords
- Alteplase, Empyema, Complicated Parapneumonic Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants
- Lead sponsor
- O'Brien, Jeana D., MD, FACP, FCCP
- Collaborators
- Genentech, Inc., Scott and White Hospital & Clinic, Scott, Sherwood and Brindley Foundation, Texas A&M University
- Study start
- Oct 2004
- First posted
- 15 Feb 2005 (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 study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.
Detailed description
This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide written informed consent
- Age greater or equal to 18 yrs
- Presence of empyema or CPE
Key exclusion criteria (9 listed)
- Active internal bleeding
- Pregnancy
- Prior enrollment in this study
- Platelet count less than 100,000/mm3
- Use of warfarin sodium if INR is greater than 1.7
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 |
|---|---|---|
| Alteplase | Drug | – |
Primary outcome
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
4 secondary outcomes
Mortality
Hospital length of stay
Daily chest tube drainage
Radiographic improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2006.
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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.
Jeana D O'Brien, MD, FACP, FCCP principal investigator
Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation
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 Empyema and Pleural Effusion, run by O'Brien, Jeana D., MD, FACP, FCCP 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 9 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: status not confirmed, as of the sponsor's last update on 1 Aug 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delores Gautier, RN, MSN (254-724-1769, lgautier@swmail.sw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.. 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 1 Aug 2006.