Pharmacokinetic Response to BPI in Burns

Phase IIa Trial to Evaluate the Pharmacokinetic Response to Bactericidal/Permeability-increasing Protein (rBPI21) for the Treatment of Patients With Burn Injury.

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.

Study Overview

• Status: Terminated
• Conditions: Burns
• Intervention / Treatment: Drug: BPI

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9158
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPI infusion group; BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours	Drug: BPI; BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours; Other Names: Opebacan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Levels of BPI	pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.	48 hours of infusion and 24 hours post infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Parameters	Routine physiologic and laboratory parameters will be followed for 28 days post infusion. These will include vital signs, cardiac enzymes, renal and hepatic function.	28 days

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Joseph P Minei, MD, UT Southwesten Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: April 17, 2007
• First Submitted That Met QC Criteria: April 17, 2007
• First Posted (Estimate): April 19, 2007

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: XO-400761