Trial Outcomes & Findings for Pharmacokinetic Response to BPI in Burns (NCT NCT00462904)
NCT ID: NCT00462904
Last Updated: 2019-11-20
Results Overview
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
48 hours of infusion and 24 hours post infusion
Results posted on
2019-11-20
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Pharmacokinetic Response to BPI in Burns
Baseline characteristics by cohort
| Measure |
BPI Infusion Group
n=4 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION .75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours of infusion and 24 hours post infusionPopulation: 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.
pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
Routine physiologic and laboratory parameters will be followed for 28 days post infusion. These will include vital signs, cardiac enzymes, renal and hepatic function.
Outcome measures
Outcome data not reported
Adverse Events
BPI Infusion Group
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BPI Infusion Group
n=4 participants at risk
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
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
PAIN
|
25.0%
1/4 • Number of events 6 • 2 years
study suspended
|
Other adverse events
| Measure |
BPI Infusion Group
n=4 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
50.0%
2/4 • Number of events 2 • 2 years
study suspended
|
|
Psychiatric disorders
AGGITATION
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
ALKALOSIS
|
25.0%
1/4 • Number of events 5 • 2 years
study suspended
|
|
Blood and lymphatic system disorders
ANEMIA
|
100.0%
4/4 • Number of events 5 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
ANOREXIA
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Psychiatric disorders
ANXIETY
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Renal and urinary disorders
AZOTEMIA
|
75.0%
3/4 • Number of events 5 • 2 years
study suspended
|
|
Cardiac disorders
BRADYCARDIA
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Infections and infestations
CELLULITIS/ABSCESS
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
2/4 • Number of events 2 • 2 years
study suspended
|
|
Investigations
DECREASED PRE-ALBUMIN
|
50.0%
2/4 • Number of events 2 • 2 years
study suspended
|
|
General disorders
FEVER
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Nervous system disorders
HEADACHE
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Gastrointestinal disorders
HEMORRHAGE
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPERCHLORIDEMIA
|
50.0%
2/4 • Number of events 2 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
50.0%
2/4 • Number of events 2 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATEMIA
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Vascular disorders
HYPERTENSION
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
25.0%
1/4 • Number of events 3 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
4/4 • Number of events 7 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
4/4 • Number of events 5 • 2 years
study suspended
|
|
Gastrointestinal disorders
Ileus, GI
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Investigations
Increased C-Reactive Protein
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Investigations
Increased CRP
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Infections and infestations
Infection Bladder
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Infections and infestations
Infection Pneumonia
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Infections and infestations
Infection Cellulitis
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Infections and infestations
Infection Skin
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Infections and infestations
Infection Skin Cellulitis
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Psychiatric disorders
Insomnia
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Skin and subcutaneous tissue disorders
Itching
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Blood and lymphatic system disorders
Leukocytosis
|
100.0%
4/4 • Number of events 5 • 2 years
study suspended
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 3 • 2 years
study suspended
|
|
Injury, poisoning and procedural complications
Oversedation
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Investigations
Pain
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Blood and lymphatic system disorders
Polycythemia
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
75.0%
3/4 • Number of events 3 • 2 years
study suspended
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
100.0%
4/4 • Number of events 4 • 2 years
study suspended
|
|
Metabolism and nutrition disorders
Vol Overload
|
50.0%
2/4 • Number of events 2 • 2 years
study suspended
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • 2 years
study suspended
|
Additional Information
Joseph Minei
University of Texas Southwestern Medical Center
Phone: 214-648-3917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place