Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: Ceftazidime-avibactam

• Registration Number: NCT04358991
• Lead Sponsor: University of Pittsburgh

Brief Summary

Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363

Detailed Description

Patients who received ceftazidime-avibactam as part of their clinical care were consented. EMR data was collected as well as PK sampling around their dosing to include the following samples immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, and 8 hours. Blood samples were collected in lithium-heparin tubes from a central venous catheter that is not being used for the continuous venovenous hemodiafiltration. The tubes were centrifuged at 2500 rpm for 10 minutes within 1 hour from collection and the samples will be frozen at 80°C. The total concentrations of ceftazidime and avibactam were determined simultaneously from plasma by using a validated HPLC-tandem MS assay. Noncompartmental pharmacokinetics were calculated using the linear-up and logarithmic-down trapezoidal method, based on the assumption of first-order elimination.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Results First Submitted: 2020-04-25
• Results First Submitted QC: 2020-05-01
• Results First Posted: 2020-05-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients receiving ceftazidime-avibactam as standard care

Exclusion Criteria

• Less than 18 years-old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
invasive bacterial infections	Ceftazidime-avibactam	patients who are receiving Ceftazidime-avibactam are asked to provide blood samples around a dosing of the medication for analysis of samples

Primary Outcome Measures

Name	Time	Method
Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients	8 hours	PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States