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

November 9, 2018 updated by: Gary E. Stein, Pharm.D., Michigan State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Drug: Ceftazidime/avibactam
Ceftazadime/avibactam dosing in ICU patients
Other Names:
  • Avycaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
Time Frame: 2,4,6, 8 hours after receiving the drug
2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
Time Frame: 2,4,6, 8 hours after receiving the drug
2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients
Time Frame: 2,4,6, 8 hours after receiving the drug
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
Time Frame: 2,4,6, 8 hours after receiving the drug
2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients
Time Frame: 2,4,6, 8 hours after receiving the drug
2,4,6, 8 hours after receiving the drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Investigators

  • Principal Investigator: Gary E Stein, PharmD, Michigan State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-USA-000832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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