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

Michigan State University

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of Avycaz in ICU Patients

Treatments: Drug: Ceftazidime/avibactam

Study type: Interventional

Funder types: Other

Identifiers

NCT02822950

IIT-USA-000832

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ceftazadime/avibactam

Other group

Description:

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.

Treatment:

Drug: Ceftazidime/avibactam