Burns
Conditions
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.
Interventions
DRUGBPI
BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Levels of BPI | 48 hours of infusion and 24 hours post infusion | pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Parameters | 28 days | Routine physiologic and laboratory parameters will be followed for 28 days post infusion. These will include vital signs, cardiac enzymes, renal and hepatic function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BPI Infusion Group BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours
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 | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | BPI Infusion Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 0.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Plasma Levels of BPI
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
Time frame: 48 hours of infusion and 24 hours post infusion
Population: This study was terminated early by the sponsor. Ownership of the company changed, and there was no longer a desire to continue the trial; therefore, no analysis was performed. No data was collected.
Secondary
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.
Time frame: 28 days
Population: This study was terminated early by the sponsor. Ownership of the company changed, and there was no longer a desire to continue the trial; therefore, no analysis was performed. No data was collected.