Trial Outcomes & Findings for Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns (NCT NCT03002506)
NCT ID: NCT03002506
Last Updated: 2021-03-02
Results Overview
Liters/hour (continuous values)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
24 hours
Results posted on
2021-03-02
Participant Flow
Participant milestones
| Measure |
Ceftolozane/Tazobactam
One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.
Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns
Baseline characteristics by cohort
| Measure |
Ceftolozane/Tazobactam
n=6 Participants
One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.
Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
42.67 years
STANDARD_DEVIATION 13.91 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 24 hoursLiters/hour (continuous values)
Outcome measures
| Measure |
Ceftolozane/Tazobactam
n=6 Participants
One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.
Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
|
|---|---|
|
Ceftolozane Clearnace
|
7.79 Liters per hour
Standard Deviation 2.30
|
Adverse Events
Ceftolozane/Tazobactam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60