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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02822950

Enrollment

Registered

2016-07-06

Start date

2017-01-31

Completion date

2017-12-31

Last updated

2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics of Avycaz in ICU Patients

Brief summary

The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.

Interventions

DRUGCeftazidime/avibactam

Ceftazadime/avibactam dosing in ICU patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, IA infections and pneumonia (including VAP) * Patients requiring intensive care (critically ill patients) in the med/surg ICU (APACHE II score ≥ 15) * Patients prescribed Avycaz for their infection will receive FDA recommended dosages and times of administration * Written informed consent

Exclusion criteria

* Pregnant Patients, patients older than 90 y/o, those with CrCl \< 30 mL/min, patients with a BMI \> 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study

Design outcomes

Primary

Measure	Time frame
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients	2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients	2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients	2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients	2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients	2,4,6, 8 hours after receiving the drug

Participant flow

Participants by arm

Arm	Count
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	10
Total	10

Baseline characteristics

Characteristic	Ceftazadime/Avibactam	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	3 Participants	—
Age, Categorical Between 18 and 65 years	7 Participants	—
Age, Continuous	55 years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	10 Participants	—
Sex: Female, Male Female	4 Participants	—
Sex: Female, Male Male	6 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 10
other Total, other adverse events	0 / 10
serious Total, serious adverse events	0 / 10