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

Sponsor
Temple University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03243864
Collaborator
Allergan (Industry)
10
Enrollment
1
Location
43.3
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

Study Type:
Observational
Anticipated 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 :
Mar 13, 2017
Anticipated Primary Completion Date :
Mar 21, 2020
Anticipated Study Completion Date :
Oct 21, 2020

Arms and Interventions

Arm 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 Names:
  • Avycaz

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ceftazidime plasma concentrations [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 [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 [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 [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) [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 [Days 1-30]

      Measure of safety

    3. Minimum plasma concentration (Cmin) [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) [8-hours]

      hours

    5. Clearance (Cl) [8-hours]

      L/hr

    6. AUC 0 to 8 hours [8-hours]

      mg*hr/L

    7. Sieving Coefficient [8-hours]

      SC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Temple University Hospital Philadelphia Pennsylvania United States 19140

    Sponsors and Collaborators

    • Temple University
    • Allergan

    Investigators

    • Principal Investigator: Christina Rose, Pharm.D., Temple University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT03243864
    Other Study ID Numbers:
    • 866
    First Posted:
    Aug 9, 2017
    Last Update Posted:
    Apr 10, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Bacterial Infections
    Renal Insufficiency
    Critical Illness
    Ceftazidime
    Avibactam
    Avibactam, ceftazidime drug combination

    Study Results

    No Results Posted as of Apr 10, 2019