Clinical trial NCT00462904: Pharmacokinetic Response to BPI in Burns
Official title: Phase IIa Trial to Evaluate the Pharmacokinetic Response to Bactericidal/Permeability-increasing Protein (rBPI21) for the Treatment of Patients With Burn Injury.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Burns
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2007-04-19
Enrollment: 4
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Plasma Levels of BPI
timeFrame: 48 hours of infusion and 24 hours post infusion
Secondary outcomes:
measure: Safety Parameters
timeFrame: 28 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwesten Medical Center
name: Joseph P Minei, MD
role: PRINCIPAL_INVESTIGATOR
References: