Pharmacokinetic Response to BPI in Burns

NCT ID: NCT00462904

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-11-30

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.

Conditions

Burns

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BPI infusion group

BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours

Group Type: EXPERIMENTAL

BPI

Intervention Type: DRUG

BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Opebacan

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph P. Minei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph P Minei, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwesten Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

XO-400761

Identifier Type: -

Identifier Source: org_study_id