Trial Outcomes & Findings for Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis (NCT NCT02504827)
NCT ID: NCT02504827
Last Updated: 2018-11-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
8 hours
Results posted on
2018-11-27
Participant Flow
Participant milestones
| Measure |
IV Ceftazidime/Avibactam
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
IV Ceftazidime/Avibactam
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
|
|---|---|
|
Overall Study
Could not produce sputum
|
1
|
Baseline Characteristics
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
IV Ceftazidime/Avibactam
n=12 Participants
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 hoursOutcome measures
| Measure |
IV Ceftazidime/Avibactam
n=12 Participants
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
|
|---|---|
|
Peak Plasma Concentration (Cmax)
|
85.87 mg/L
Interval 61.8 to 111.2
|
PRIMARY outcome
Timeframe: 8 hoursOutcome measures
| Measure |
IV Ceftazidime/Avibactam
n=11 Participants
Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
|
|---|---|
|
Peak Sputum Concentration
|
2.5 mg/L
Interval 0.6 to 9.4
|
Adverse Events
IV Ceftazidime/Avibactam
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