Thinking of joining a study?

Register your interest

NCT05367011 | Not yet recruiting | Intensive Care Unit


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

Poitiers University Hospital

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

Intensive Care Unit

Antibiotic Therapy

Pharmacokinetic

Study Type : Observational
Estimated Enrollment : 2500 participants
Official Title : Cohort Study of Therapeutic Monitoring of Antibiotic Therapy in Intensive Care Patients
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : September 1, 2028

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Loading...