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

Pharmacokinetics of Avycaz in ICU Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822950
• Other study ID #: IIT-USA-000832
• Status: Completed
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Pharmacokinetics of Avycaz in ICU Patients

Intervention

Drug:
• Ceftazidime/avibactam
Ceftazadime/avibactam dosing in ICU patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Outcome

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