Trial Outcomes & Findings for A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients (NCT NCT02822950)
NCT ID: NCT02822950
Last Updated: 2019-03-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
2,4,6, 8 hours after receiving the drug
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Ceftazadime/Avibactam
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ceftazadime/Avibactam
n=10 Participants
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=10 Participants
|
|
Age, Continuous
|
55 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 2,4,6, 8 hours after receiving the drugOutcome measures
| Measure |
Ceftazadime/Avibactam
n=10 Participants
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
|
34 Liter
Standard Deviation 12
|
PRIMARY outcome
Timeframe: 2,4,6, 8 hours after receiving the drugOutcome measures
| Measure |
Ceftazadime/Avibactam
n=10 Participants
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
|
4.3 Hours
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 2,4,6, 8 hours after receiving the drugOutcome measures
| Measure |
Ceftazadime/Avibactam
n=10 Participants
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients
|
6.4 Liters/hour
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: 2,4,6, 8 hours after receiving the drugOutcome measures
| Measure |
Ceftazadime/Avibactam
n=10 Participants
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients
|
343 mg*hour/liters
Standard Deviation 47
|
PRIMARY outcome
Timeframe: 2,4,6, 8 hours after receiving the drugOutcome measures
| Measure |
Ceftazadime/Avibactam
n=10 Participants
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients
|
|---|---|
|
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients
|
48 mg/liter
Standard Deviation 17
|
Adverse Events
Ceftazadime/Avibactam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 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