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

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

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients receiving ceftazidime-avibactam as standard care

Exclusion criteria

Less than 18 years-old

Treatment and study plan

Ceftazidime-avibactam

Drug

collection of blood samples around clinical dosing immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, 8, and 12 hours and EMR review.

Primary outcomes

Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients

Time frame: 8 hours

PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

Allergan

Registry information

Official study title

Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving Continuous Venovenous Hemodiafiltration

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Apr 24, 2020
Registry last updated: Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed