CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Ceftazidime/avibactamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02822950
NCT02822950Phase 1Completed
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A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients

Michigan State University·interventional·Posted Jul 6, 2016·Updated Mar 6, 2019

In Brief

A Phase 1 clinical trial evaluating Ceftazidime/avibactam for Pharmacokinetics of Avycaz in ICU Patients. Completed, enrolled 10 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics of Avycaz in ICU Patients
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 6, 2016
Enrollment StartJan 1, 2017
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.0 years ago

Interventions

Ceftazidime/avibactamdrug

Ceftazadime/avibactam dosing in ICU patients