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NCT Number: NCT05367011

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

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.

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Key information

Conditions

Intensive Care Unit Antibiotic Therapy Pharmacokinetic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire DAHYOT-FIZELIER, Pr

CONTACT

[email protected]

(+33)5.49.44.48.40

Karine ESTEVE-GARNIER

CONTACT

[email protected]

(+33)5.49.44.35.67

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Etude de Cohorte de Suivi thérapeutique de l'antibiothérapie Chez Les Patients de réanimation

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 10, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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