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Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT03438981
Collaborator
KU Leuven (Other)
30
Enrollment
1
Location
77.9
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    First, the investigators will document exposure to ceftriaxone in plasma and epithelial lining fluid.

    Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.

    Finally in a small subset of ECMO patients PK exposure will be explored.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact op Capillary Leak and Hypoalbuminemia on PK/PD of Ceftriaxone in Critically Ill Patients With Overwhelming Pneumonia
    Actual Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Feb 1, 2018
    Actual Study Completion Date :
    Jul 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Risk factors for target non attainment [on day of sampling]

      risk factors will be assessed by comparing patients who attain target vs. those who don't

    Eligibility Criteria

    Criteria

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

    • Pneumonia

    • Admitted to an ICU ward

    • Treated with ceftriaxone

    Exclusion Criteria:

    • Pregnancy

    • DNR code 2-3

    • Renal replacement therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZLeuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven
    • KU Leuven

    Investigators

    • Study Director: Isabel Spriet, PhD PharmD, isabel.spriet@uzleuven.be

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthias Gijsen, PharmD, Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT03438981
    Other Study ID Numbers:
    • ML8457
    First Posted:
    Feb 20, 2018
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Matthias Gijsen, PharmD, Universitaire Ziekenhuizen Leuven
    Pharmacokinetics
    Ceftriaxone
    critical illness
    capillary leak
    hypoalbuminemia
    Additional relevant MeSH terms:
    Pneumonia
    Hypoalbuminemia
    Critical Illness

    Study Results

    No Results Posted as of Apr 28, 2021