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

NCT ID: NCT05367011

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2028-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Claire DAHYOT-FIZELIER, Pr

Role: CONTACT

claire.dahyot-fizelier@chu-poitiers.fr

(+33)5.49.44.48.40

Karine ESTEVE-GARNIER

Role: CONTACT

karine.garnier@chu-poitiers.fr

(+33)5.49.44.35.67

Other Identifiers

PopTDM-ICU

Identifier Type: -

Identifier Source: org_study_id