Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock

Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock

Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.

Inclusion Criteria:

• The patient or their legal representative must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient has septic shock according to the SEPSIS-3 definition in the 24 hours preceding inclusion, regardless of the source of infection
• Patient having already received a first dose of amikacin in the 22 preceding hours
• Patient with an expectation of receiving at least 2 doses of amikacin
• Patient with available amikacin therapeutic drug monitoring

Exclusion Criteria:

• The subject is participating in an interventional study that could influence the primary outcome, or is in a period of exclusion determined by a previous study
• The patient is pregnant, parturient or breastfeeding
• Patient has a contra-indication or an allergy to treatment by amikacin
• Patient is not expected to survive beyond 48 hours