NCT03243864

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure
• Bacterial Infections
• Critical Illness

Interventions

Type	Name	Description
DRUG	Ceftazidime-avibactam	Patients will be started on 2.5 gm IV every 8 hours

Timeline

• Start date: 2017-03-13
• Primary completion: 2020-03-21
• Completion: 2020-10-21
• First posted: 2017-08-09
• Last updated: 2019-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study