Trial Outcomes & Findings for Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery (NCT NCT00701636)
NCT ID: NCT00701636
Last Updated: 2016-08-29
Results Overview
Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Hospital discharge or 7 days, whichever comes first
Results posted on
2016-08-29
Participant Flow
From July 2008 to August 2010, we recruited subjects undergoing CABG surgery at Harbor-UCLA Medical Center, a 400-bed tertiary-care county hospital.
Participant milestones
| Measure |
Cases
The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
|
Controls
15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Baseline characteristics by cohort
| Measure |
Cases
n=15 Participants
The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
|
Controls
n=15 Participants
15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
57 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
56 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hospital discharge or 7 days, whichever comes firstPopulation: Based on sample sizes from previously published studies on antibiotic pk for CABG surgery.
Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h
Outcome measures
| Measure |
Cases
n=15 Participants
The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis for CABG.
|
|---|---|
|
Mean Daptomycin Concentrations at 12, 18, 24, and 48 h
mean daptomycin concentration at 12 hours
|
22.7 mcg/ml
Standard Deviation 9.7
|
|
Mean Daptomycin Concentrations at 12, 18, 24, and 48 h
mean daptomycin concentration at 18 hours
|
16.2 mcg/ml
Standard Deviation 8.2
|
|
Mean Daptomycin Concentrations at 12, 18, 24, and 48 h
mean daptomycin concentration at 24 hours
|
12.0 mcg/ml
Standard Deviation 4.7
|
|
Mean Daptomycin Concentrations at 12, 18, 24, and 48 h
mean daptomycin concentration at 48 hours
|
3.5 mcg/ml
Standard Deviation 2.3
|
Adverse Events
Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cases
n=15 participants at risk
The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
|
Controls
n=15 participants at risk
15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
|
|---|---|---|
|
Surgical and medical procedures
Surgical site infection
|
0.00%
0/15 • 30 days
|
20.0%
3/15 • Number of events 3 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Loren Miller MD
LA BioMed at Harbor-UCLA Medical Center
Phone: 310-222-3813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place