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Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU

Sponsor
Poitiers University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05367011
Collaborator
(none)
2,500
Enrollment
72
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018.

The main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring).

This study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Etude de Cohorte de Suivi thérapeutique de l'antibiothérapie Chez Les Patients de réanimation
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2028
    Anticipated Study Completion Date :
    Sep 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Clinical therapeutic efficacy at the end treatment or at day 14 in the event of prolonged treatment, defined by the combination of the following 3 points. [up to 14 days]

      A disappearance of all signs and symptoms of infection, or a marked decrease in the severity of infection defined by evolution of Sequential Organ Failure Assessment (SOFA) Score. SOFA score describes the time course of multiple organ dysfunction using a limited number of routinely measured variables. The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24. Absence of necessary therapeutic escalation during the duration of treatment No antibiotic treatment for the same pathology within 48 hours of stopping treatment.

    Eligibility Criteria

    Criteria

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

    • Patient ≥ 18 year-old.

    • Patient hospitalized in intensive care,

    • Patient receiving an antibiotic for sepsis or septic shock

    • Patient or family member who does not object to participating in the study

    Exclusion Criteria:

    Patient at risk of death, for a cause other than infectious, within 48 hours following the introduction of antibiotic therapy.

    • Patient receiving antibiotic treatment for antibiotic prophylaxis.

    • Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.

    • Pregnant and / or lactating women.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Poitiers University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poitiers University Hospital
    ClinicalTrials.gov Identifier:
    NCT05367011
    Other Study ID Numbers:
    • PopTDM-ICU
    First Posted:
    May 10, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Poitiers University Hospital
    Antibiotic
    Intensive care
    Therapeutic drug monitoring

    Study Results

    No Results Posted as of Aug 4, 2022