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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2022-12-02

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.

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Detailed Description

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Conditions

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Shock, Septic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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BestDose

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Group Type EXPERIMENTAL

Amikacin dose optimization

Intervention Type OTHER

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amikacin dose optimization

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No