Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis

: Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration

The study's primary objective is to determine plasma and dialysis fluid concentrations in patients prescribed ceftazidime-avibactam as the standard treatment for their infection and requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the prescribed dose meets pharmacodynamic targets.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Bacterial Infections; Renal Failure
• Intervention / Treatment: Drug: Ceftazidime-avibactam

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital
      • Contact: Christina Rose, Pharm.D.; Phone Number: 215-707-8057; Email: rosecm@temple.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

Description

Inclusion Criteria:

• Adults > 18 years of age
• Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure
• documented or suspected infection requiring a prescription for ceftazidime-avibactam

Exclusion Criteria:

• Patients on CRRT < 24 hours
• Patients on ceftazidime-avibactam < 24 hours
• Patients unable to remain on CRRT for 32 hours continuously without clotting

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ceftazidime and Avibactam; Ceftazidime-avibactam pharmacokinetic monitoring	Drug: Ceftazidime-avibactam; Patients will be started on 2.5 gm IV every 8 hours; Other Names: Avycaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ceftazidime plasma concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Avibactam plasma concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Ceftazidime effluent concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Avibactam effluent concentrations	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Number of participants with adverse effects as a measure of safety	Measure of safety	Days 1-30
Minimum plasma concentration (Cmin)	mg/L	At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Half-life (t1/2)	hours	8-hours
Clearance (Cl)	L/hr	8-hours
AUC 0 to 8 hours	mg*hr/L	8-hours
Sieving Coefficient	SC	8-hours

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Allergan
• Investigators: Principal Investigator: Christina Rose, Pharm.D., Temple University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2017
• Primary Completion (ANTICIPATED): March 21, 2020
• Study Completion (ANTICIPATED): October 21, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (ACTUAL): August 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Disease Attributes; Bacterial Infections and Mycoses; Renal Insufficiency; Critical Illness; Bacterial Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Avibactam; Ceftazidime; Avibactam, ceftazidime drug combination
• Other Study ID Numbers: 866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No