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

• Conditions: Renal Failure; Bacterial Infections; Critical Illness
• Interventions: Drug: Ceftazidime-avibactam

• Registration Number: NCT03243864
• Lead Sponsor: Temple University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10
• Primary Completion: 2020-03-21
• Study Completion: 2020-10-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ceftazidime and Avibactam	Ceftazidime-avibactam	Ceftazidime-avibactam pharmacokinetic monitoring

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States