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

Intensive Care Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05367011
• Other study ID #: PopTDM-ICU
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2028

Study information

• Verified date: May 2022
• Source: Poitiers University Hospital
• Contact: Claire DAHYOT-FIZELIER, Pr
• Phone: (+33)5.49.44.48.40
• Email: claire.dahyot-fizelier[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Therapy
• Intensive Care Unit
• Pharmacokinetic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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