Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

This study is currently recruiting participants.

Verified by O'Brien, Jeana D., MD, FACP, FCCP, July 2006

First Received: February 14, 2005 Last Updated: July 31, 2006 History of Changes

Sponsor:	O'Brien, Jeana D., MD, FACP, FCCP
Collaborators:	Genentech Scott and White Memorial Hospital Scott, Sherwood and Brindley Foundation Texas A&M University
Information provided by:	O'Brien, Jeana D., MD, FACP, FCCP
ClinicalTrials.gov Identifier:	NCT00103766

Purpose

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
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

Resource links provided by NLM:

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by O'Brien, Jeana D., MD, FACP, FCCP:

Primary Outcome Measures:

Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.

Secondary Outcome Measures:

Mortality
Hospital length of stay
Daily chest tube drainage
Radiographic improvement

Estimated Enrollment:	75
Study Start Date:	October 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to provide written informed consent
Age greater or equal to 18 yrs
Presence of empyema or CPE

Exclusion Criteria:

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
Known neurological disorders
Current or pre-existing bleeding dyscrasia
Known allergy to Alteplase

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103766

Contacts

Contact: Delores Gautier, RN, MSN

254-724-1769

lgautier@swmail.sw.org

Locations

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

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

Investigators

Principal Investigator:

Jeana D O'Brien, MD, FACP, FCCP

Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation

More Information

No publications provided

Study ID Numbers:	8736
Study First Received:	February 14, 2005
Last Updated:	July 31, 2006
ClinicalTrials.gov Identifier:	NCT00103766 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by O'Brien, Jeana D., MD, FACP, FCCP:

Alteplase
Empyema
Complicated Parapneumonic Effusion

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Pleural Diseases
Hematologic Agents
Tissue Plasminogen Activator
Empyema
Fibrinolytic Agents
Cardiovascular Agents
Infection

Pharmacologic Actions
Inflammation
Pleural Effusion
Fibrin Modulating Agents
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Suppuration

ClinicalTrials.gov processed this record on November 20, 2009