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

University of Pittsburgh logo

University of Pittsburgh

Status

Completed

Conditions

Bacterial Infections

Treatments

Drug: Ceftazidime-avibactam

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04358991
I# 0058410

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients receiving ceftazidime-avibactam as standard care

Exclusion criteria

  • Less than 18 years-old

Trial design

20 participants in 1 patient group

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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