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SPT BETALACT: Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT05352997
Collaborator
(none)
156
Enrollment
1
Location
38
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital.

The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients.

Clinical and biological features, as well as risk scores are collected and recorded into an electronic Case Report Form.

The primary outcome is to show the main characteristics related to adequate beta-lactams serum concentrations in critically ill inpatients.

Secondary outcomes include the key factors related to inadequate beta-lactams serum concentrations in critically ill inpatients, Therapeutic Drug Monitoring (TDM) impact in the achievement of target beta-lactams serum concentration and the correlation between Aminoglycosides and Beta-lactams serum concentrations. Do both antibiotics have similar elimination kinetics ?

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    156 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Key Factors of Target Serum Concentrations Attainment From Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Mar 4, 2021
    Actual Study Completion Date :
    Mar 4, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1: on-target beta-lactams serum concentration

    Patients with on-target beta-lactams serum concentration during 1st dosing
    Group 2: off-target beta-lactams serum concentration

    Patients with off-target beta-lactams serum concentrations during 1st dosing
    Group 3: off-target beta-lactams plasma concentration:

    Patients with high beta-lactams plasma concentrations during 1st dosing

    Outcome Measures

    Primary Outcome Measures

    1. To identify factors associated with adequate beta lactam plasma concentrations on the first sample [Day 7]

      Determinants of adequate beta-lactams plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM

    Secondary Outcome Measures

    1. To identify factors related with on-target beta-lactams plasma concentrations on the second sample [Day 7]

      Risk factors of inadequate beta-lactam plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM.

    2. To identify factors related with on-target beta-lactams plasma concentrations on the second sample [Day 7]

      Proportion of on target 2nd dosing after inadequate first dosing

    3. Impact of TDM [Day 7]

      Mean number of TDM per patient with off-target first dosing and delay to achieve target plasma concentrations.

    4. To assess if beta-lactams and Aminoglycosides have the same elimination kinetic [Day 7]

      Linkage between beta-lactams and aminoglycosides' trough concentrations for patients concurrently treated by both antibiotics.

    Eligibility Criteria

    Criteria

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

    • Patient aged at least (≥) 18 years of age.

    • Patient (or his representative for patients unable to give their consent) has given his free and informed consent and has signed the consent form.

    • Patient affiliated to the health insurance scheme

    • Patient hospitalized in one of the critical care services of Nimes' community hospital with at least one beta-lactam treatment

    • Patient with at least one beta-lactam TDM during his stay

    Exclusion Criteria :

    • Patient who did not consent the use of his personal data

    • Patients under maintenance of justice, tutelage or legal guardianship

    • Patient previously included in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Principal Investigator: Claire ROGER, MD, PhD, Centre Hospitalier Universitaire de Nîmes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT05352997
    Other Study ID Numbers:
    • LOCAL/2021/HG-01
    First Posted:
    Apr 29, 2022
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    beta-lactam
    lCU
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections

    Study Results

    No Results Posted as of Apr 29, 2022