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Trial record 12 of 29 for:    ceftazidime AND avibactam

A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02822950
Recruitment Status : Completed
First Posted : July 6, 2016
Results First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University

Brief Summary:
The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.

Condition or disease Intervention/treatment Phase
Pharmacokinetics of Avycaz in ICU Patients Drug: Ceftazidime/avibactam Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ceftazadime/avibactam
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours [other antibiotics can also be administered as needed]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Drug: Ceftazidime/avibactam
Ceftazadime/avibactam dosing in ICU patients
Other Name: Avycaz




Primary Outcome Measures :
  1. Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients [ Time Frame: 2,4,6, 8 hours after receiving the drug ]
  2. Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients [ Time Frame: 2,4,6, 8 hours after receiving the drug ]
  3. Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients [ Time Frame: 2,4,6, 8 hours after receiving the drug ]
  4. Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients [ Time Frame: 2,4,6, 8 hours after receiving the drug ]
  5. Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients [ Time Frame: 2,4,6, 8 hours after receiving the drug ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, IA infections and pneumonia (including VAP)
  • Patients requiring intensive care (critically ill patients) in the med/surg ICU (APACHE II score ≥ 15)
  • Patients prescribed Avycaz for their infection will receive FDA recommended dosages and times of administration
  • Written informed consent

Exclusion Criteria:

  • Pregnant Patients, patients older than 90 y/o, those with CrCl < 30 mL/min, patients with a BMI > 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822950


Sponsors and Collaborators
Michigan State University
Investigators
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Principal Investigator: Gary E Stein, PharmD Michigan State University
  Study Documents (Full-Text)

Documents provided by Gary E. Stein, Pharm.D., Michigan State University:

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Responsible Party: Gary E. Stein, Pharm.D., Professor of Medicine, Michigan State University
ClinicalTrials.gov Identifier: NCT02822950     History of Changes
Other Study ID Numbers: IIT-USA-000832
First Posted: July 6, 2016    Key Record Dates
Results First Posted: March 6, 2019
Last Update Posted: March 6, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Critical Illness
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action