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Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis

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ClinicalTrials.gov Identifier: NCT03243864
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Temple University

Brief 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.

Condition or disease Intervention/treatment
Renal Failure Bacterial Infections Critical Illness Drug: Ceftazidime-avibactam

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: : Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : March 21, 2020
Estimated Study Completion Date : October 21, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ceftazidime and Avibactam
Ceftazidime-avibactam pharmacokinetic monitoring
Drug: Ceftazidime-avibactam
Patients will be started on 2.5 gm IV every 8 hours
Other Name: Avycaz




Primary Outcome Measures :
  1. Ceftazidime plasma concentrations [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]
    mg/L

  2. Avibactam plasma concentrations [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]
    mg/L

  3. Ceftazidime effluent concentrations [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]
    mg/L

  4. Avibactam effluent concentrations [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]
    mg/L


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]
    mg/L

  2. Number of participants with adverse effects as a measure of safety [ Time Frame: Days 1-30 ]
    Measure of safety

  3. Minimum plasma concentration (Cmin) [ Time Frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) ]
    mg/L

  4. Half-life (t1/2) [ Time Frame: 8-hours ]
    hours

  5. Clearance (Cl) [ Time Frame: 8-hours ]
    L/hr

  6. AUC 0 to 8 hours [ Time Frame: 8-hours ]
    mg*hr/L

  7. Sieving Coefficient [ Time Frame: 8-hours ]
    SC


Biospecimen Retention:   None Retained
Whole blood, plasma, effluent fluid from dialysis machine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients
Criteria

Inclusion Criteria:

  • Adults > 18 years of age
  • Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure
  • documented or suspected infection requiring a prescription for ceftazidime-avibactam

Exclusion Criteria:

  • Patients on CRRT < 24 hours
  • Patients on ceftazidime-avibactam < 24 hours
  • Patients unable to remain on CRRT for 32 hours continuously without clotting

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): NCT03243864


Contacts
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Contact: Christina Rose, Pharm.D. 215-707-8057 rosecm@temple.edu
Contact: Daniel Mueller, MD 215-707-1982 Daniel.Mueller2@tuhs.temple.edu

Locations
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United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Christina Rose, Pharm.D.    215-707-8057    rosecm@temple.edu   
Sponsors and Collaborators
Temple University
Allergan
Investigators
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Principal Investigator: Christina Rose, Pharm.D. Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03243864     History of Changes
Other Study ID Numbers: 866
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Bacterial Infections
Renal Insufficiency
Critical Illness
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action