Pharmacokinetic Response to BPI in Burns

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00462904
First received: April 17, 2007
Last updated: June 2, 2008
Last verified: April 2007
  Purpose

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. 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.


Condition Intervention Phase
Burns
Drug: opebacan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IIa Trial to Evaluate the Pharmacokinetic Response to Bactericidal/Permeability-Increasing Protein (rBPI21) for the Treatment of Patients With Burn Injury.

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment: 6
Study Start Date: April 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462904

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9158
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Joseph P Minei, MD UT Southwesten Medical Center
  More Information

No publications provided

Responsible Party: Joseph Minei, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00462904     History of Changes
Other Study ID Numbers: XO-400761
Study First Received: April 17, 2007
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Bactericidal permeability increasing protein
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014