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

Study Overview
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Brief Summary
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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.

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

Conditions
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Shock, Septic

Intervention / Treatment
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* Other: Amikacin dose optimization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BestDose<br>Therapeutic drug optimization of amikacin using the BestDose software algorithm | Other: Amikacin dose optimization<br>* Therapeutic drug optimization of amikacin using the BestDose software algorithm<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients reaching target amikacin maximum concentration following second dose | Yes/no; Cmax 60-80mg/l | 30 minutes after second dose of amikacin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients reaching target amikacin minimum concentration following second dose | Yes/no | 24 hours after second dose of amikacin | 
| Patients reaching target amikacin maximum concentration following third dose | Yes/no; Cmax 60-80mg/l | 30 minutes after third dose of amikacin | 
| Patients reaching target amikacin minimum concentration following third dose | Yes/no | 24 hours after third dose of amikacin | 
| Time taken to reach recommended Cmax during amikacin therapy | Hours | Maximum 7 days | 
| Clinical cure test | Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed | At end of treatment (Maximum day 7) | 
| Clinical cure test | Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed | Day 7 | 
| Number of days without renal replacement therapy | Number | Day 28 | 
| Number of days without vasopressors | Number | Day 28 | 
| Number of days without mechanical ventilation | Number | Day 28 | 
| Mortality |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, dose optimisation, aminoglycosides