Pharmacokinetic Response to BPI in Burns
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 13 - 60 |
| Updated: | 10/14/2017 |
| Start Date: | April 2006 |
| End Date: | May 2008 |
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. 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.
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.
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
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