NCT05367011

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2022-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2022-05-10
• Last updated: 2022-08-04