Pharmacokinetic Response to BPI in Burns

The University of Texas System (UT)

Status and phase

Terminated

Phase 2

Conditions

Burns

Treatments

Drug: BPI

Study type

Interventional

Funder types

Other

Identifiers

NCT00462904

XO-400761

Details and patient eligibility

About

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.

Full 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 to obtain the desired effect. The drug will be started within 8 hours of burn injury and continued for 48 hours. Patients will be followed on admission and through infusion in the Burn ICU where they will be monitored by ICU standards. They will be seen regularly thereafter on post-burn days 1, 2, 3, 4, 7, 14 and 28 days while in the hospital. If the patient is discharged prior to the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. A blood sample will be obtained to look for potential genetic markers that may increase a burn patients' risk to develop infection in the post burn period.

Enrollment

4 patients

Sex

All

Ages

13 to 60 years old

Volunteers

No Healthy Volunteers

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