Trial Outcomes & Findings for Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF (NCT NCT04358991)
NCT ID: NCT04358991
Last Updated: 2020-09-29
Results Overview
PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
8 hours
Results posted on
2020-09-29
Participant Flow
Participant milestones
| Measure |
Subjects Included
20 patients meeting inclusion criteria were enrolled into the trial
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF
Baseline characteristics by cohort
| Measure |
Subjects Included
n=20 Participants
20 patients meeting inclusion criteria were enrolled into the trial
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration
Outcome measures
| Measure |
Subjects Included
n=20 Participants
20 patients meeting inclusion criteria were enrolled into the trial
|
|---|---|
|
Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients
Ceftazidime Cmax
|
80.6 mcg/mL
Interval 61.2 to 104.1
|
|
Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients
Avibactam Cmax
|
15.9 mcg/mL
Interval 11.8 to 23.0
|
Adverse Events
Subjects Included
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ryan Shields, Associate Professor of Medicine
University of Pittsburgh
Phone: 412-864-3745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60