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Sponsors and Collaborators: |
O'Brien, Jeana D., MD, FACP, FCCP Genentech Scott and White Memorial Hospital Scott, Sherwood and Brindley Foundation Texas A&M University |
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Information provided by: | O'Brien, Jeana D., MD, FACP, FCCP |
ClinicalTrials.gov Identifier: | NCT00103766 |
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.
Condition | Intervention |
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Empyema Pleural Effusion |
Drug: Alteplase |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion |
Estimated Enrollment: | 75 |
Study Start Date: | October 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Delores Gautier, RN, MSN | 254-724-1769 | lgautier@swmail.sw.org |
United States, Texas | |
Scott and White Memorial Hospital & Clinic | Recruiting |
Temple, Texas, United States, 76508 | |
Contact: Delores Gautier, RN, MSN 254-724-1769 lgautier@swmail.sw.org | |
Principal Investigator: Jeana D O'Brien, MD, FACP, FCCP | |
Sub-Investigator: Dominic R deKeratry, MD | |
Sub-Investigator: Timothy S Mooring, MD |
Principal Investigator: | Jeana D O'Brien, MD, FACP, FCCP | Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation |
Study ID Numbers: | 8736 |
Study First Received: | February 14, 2005 |
Last Updated: | July 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00103766 |
Health Authority: | United States: Food and Drug Administration |
Alteplase Empyema Complicated Parapneumonic Effusion |
Pleural Effusion Respiratory Tract Diseases Pleural Diseases Tissue Plasminogen Activator |
Suppuration Empyema Plasminogen Inflammation |
Fibrin Modulating Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Agents Infection Pharmacologic Actions |