Pharmacokinetic Response to BPI in Burns

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Bactericidal permeability increasing protein

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

1. New York Heart Class 3 or 4 heart failure.

2. Unstable angina or acute myocardial infarction.

3. 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:

1. Known history of HIV/AIDS

2. Chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day).

3. Active oncolytic therapy for known malignancy

• Known or suspected pregnancy

• Known allergy to rBPI21