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

NCT05367011 | Not Yet Recruiting

• 1 other identifier: PopTDM-ICU
• Study Type: observational
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intensive Care Unit; Antibiotic Therapy; Pharmacokinetic

Keywords

Antibiotic; Intensive care; Therapeutic drug monitoring

Outcome Measures

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.

  * 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.

  up to 14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients with to serious infections

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Central Study Contacts

Claire DAHYOT-FIZELIER, Pr

CONTACT

(+33)5.49.44.48.40; claire.dahyot-fizelier@chu-poitiers.fr

Karine ESTEVE-GARNIER

CONTACT

(+33)5.49.44.35.67; karine.garnier@chu-poitiers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: May 10, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 4, 2022

Record last verified: 2022-05