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A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02822950
Recruitment Status : Completed
First Posted : July 6, 2016
Results First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Pharmacokinetics of Avycaz in ICU Patients
Intervention Drug: Ceftazidime/avibactam
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ceftazadime/Avibactam
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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

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description

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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  70.0%
>=65 years
3
  30.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
55
(37 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
Hide Description [Not Specified]
Time Frame 2,4,6, 8 hours after receiving the drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Liter
34  (12)
2.Primary Outcome
Title Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
Hide Description [Not Specified]
Time Frame 2,4,6, 8 hours after receiving the drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Hours
4.3  (1.9)
3.Primary Outcome
Title Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients
Hide Description [Not Specified]
Time Frame 2,4,6, 8 hours after receiving the drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Liters/hour
6.4  (3.4)
4.Primary Outcome
Title Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients
Hide Description [Not Specified]
Time Frame 2,4,6, 8 hours after receiving the drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mg*hour/liters
343  (47)
5.Primary Outcome
Title Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients
Hide Description [Not Specified]
Time Frame 2,4,6, 8 hours after receiving the drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mg/liter
48  (17)
Time Frame 1 week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ceftazadime/Avibactam
Hide Arm/Group Description

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

All-Cause Mortality
Ceftazadime/Avibactam
Affected / at Risk (%)
Total   1/10 (10.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ceftazadime/Avibactam
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ceftazadime/Avibactam
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Stein
Organization: Michigan State University
Phone: 517-353-5126
EMail: steing@msu.edu
Layout table for additonal information
Responsible Party: Gary E. Stein, Pharm.D., Michigan State University
ClinicalTrials.gov Identifier: NCT02822950     History of Changes
Other Study ID Numbers: IIT-USA-000832
First Submitted: June 28, 2016
First Posted: July 6, 2016
Results First Submitted: March 26, 2018
Results First Posted: March 6, 2019
Last Update Posted: March 6, 2019