Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock (AMINO BESTDOSE)

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.

Study Overview

• Status: Completed
• Conditions: Shock, Septic
• Intervention / Treatment: Other: Amikacin dose optimization

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: BestDose; Therapeutic drug optimization of amikacin using the BestDose software algorithm	Other: Amikacin dose optimization; Therapeutic drug optimization of amikacin using the BestDose software algorithm

What is the study measuring?

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
Mortality		Day 28
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Claire Roger, CHU Nîmes

Publications and helpful links

General Publications

• Garbez N, Mbatchi LC, Louart G, Wallis SC, Muller L, Lipman J, Roberts JA, Lefrant JY, Roger C. Micafungin Population PK Analysis in Healthy and Septic Pigs: Can the Septic Porcine Model Predict the Micafungin PK in Septic Patients? Pharm Res. 2021 Nov;38(11):1863-1871. doi: 10.1007/s11095-021-03137-2. Epub 2021 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; dose optimisation; aminoglycosides
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Anti-Infective Agents; Anti-Bacterial Agents; Amikacin
• Other Study ID Numbers: NIMAO/2018-02/CR-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No