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

NCT02822950 | Completed Phase 1 Results DMC

• 1 other identifier: IIT-USA-000832
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacokinetics of Avycaz in ICU Patients

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Ceftazadime/avibactam

OTHER

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

Interventions

Ceftazidime/avibactam DRUG

Ceftazadime/avibactam dosing in ICU patients

Also known as: Avycaz

Ceftazadime/avibactam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead

MeSH Terms

Interventions

avibactam, ceftazidime drug combination

Results Point of Contact

• Title: Gary Stein
• Organization: Michigan State University

steing@msu.edu

517-353-5126

Study Officials

• Gary E Stein, PharmD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share