Status:
TERMINATED
Pharmacokinetic Response to BPI in Burns
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Burns
Eligibility:
All Genders
13-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety of a protein called BPI that is naturally made by the body's white blood cells to fight infection.
Detailed Description
This study will initially evaluate an FDA approved investigational dosage and will measure the blood levels over time while BPI is being infused through a vein to see if the dose is potentially enough...
Eligibility Criteria
Inclusion
- Ages 13 years to 60 years old
- Sustained partial-thickness or full-thickness burn greater than 20% and less than 41% TBSA
- Parental consent (if subject is less than 18 years old) or individual (if subject is equal to or older than 18) signed, informed consent.
- Able to start BPI in infusion within 8 hours of burn injury.
Exclusion
- Age \> 61.
- Inhalational injury requiring mechanical ventilation.
- Partial and full thickness burns totaling \> 41% total body surface area
- Cardiac dysfunction, defined as the presence of any of the following:
- New York Heart Class 3 or 4 heart failure.
- Unstable angina or acute myocardial infarction.
- Left ventricular ejection fraction known to be \< 35%.
- Electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation.
- Concomitant non-burn trauma with an ISS \> 9.
- Non-survivable injury secondary to burn size - patients made DNR or comfort care due to burn size.
- Patients with known causes of immunosuppression:
- Known history of HIV/AIDS
- Chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day).
- Active oncolytic therapy for known malignancy
- Known or suspected pregnancy
- Known allergy to rBPI21
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00462904
Start Date
April 1 2006
End Date
November 1 2007
Last Update
November 20 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9158