Clinical trial NCT04178148: Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
Official title: Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock, Septic
Keywords: Pharmacokinetics
dose optimisation
aminoglycosides
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patients reaching target amikacin maximum concentration following second dose
timeFrame: 30 minutes after second dose of amikacin
Secondary outcomes:
measure: Patients reaching target amikacin minimum concentration following second dose
timeFrame: 24 hours after second dose of amikacin
measure: Patients reaching target amikacin maximum concentration following third dose
timeFrame: 30 minutes after third dose of amikacin
measure: Patients reaching target amikacin minimum concentration following third dose
timeFrame: 24 hours after third dose of amikacin
measure: Time taken to reach recommended Cmax during amikacin therapy
timeFrame: Maximum 7 days
measure: Clinical cure test
timeFrame: At end of treatment (Maximum day 7)
measure: Clinical cure test
timeFrame: Day 7
measure: Number of days without renal replacement therapy
timeFrame: Day 28
measure: Number of days without vasopressors
timeFrame: Day 28
measure: Number of days without mechanical ventilation
timeFrame: Day 28
measure: Mortality
timeFrame: Day 28
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Claire Roger
role: PRINCIPAL_INVESTIGATOR
References: