Pharmacokinetic Response to BPI in Burns

Stopped early · Phase 2

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT00462904

Run by

University of Texas Southwestern Medical Center

People needed

4

Starts

2006-04-01

Expected to finish

2007-11-01

Last updated by the study team

2019-11-20

Who can join

Age: 13 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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