Phase 1
N=10
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Pharmacokinetics of Avycaz in ICU Patients
Bottom Line
View on ClinicalTrials.gov: NCT02822950 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients — 34 Liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ceftazidime/avibactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients |
34 | — |
| PRIMARY Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients |
4.3 | — |
| PRIMARY Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients |
6.4 | — |
| PRIMARY Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients |
343 | — |
| PRIMARY Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients |
48 | — |
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.
Eligibility Criteria
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 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study
Data sourced from ClinicalTrials.gov (NCT02822950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.