A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Completed
Michigan State University
Phase 1
2017-01-01
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.
A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam
Completed
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2019-07-09
This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male
and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and
pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ
alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration
treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion
(CI), ATM per label dosing, and ATM as a CI. Arms 5 and 6 are the two AVYCAZ and ATM
combination drug administration treatment groups. The duration of subject participation will
be up to 44 days, and the total length of the study will be 15 months. The primary objective
of this study is to describe the safety of two dosing regimens of AVYCAZ combined with ATM
relative to AVYCAZ alone, and ATM alone in healthy adult subjects.
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