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

NCT04178148 | Completed

• 1 other identifier: NIMAO/2018-02/CR-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Septic

Keywords

Pharmacokinetics; dose optimisation; aminoglycosides

Outcome Measures

Primary Outcomes (1)

• Patients reaching target amikacin maximum concentration following second dose

  Yes/no; Cmax 60-80mg/l

  30 minutes after second dose of amikacin

Secondary Outcomes (10)

• Patients reaching target amikacin minimum concentration following second dose

  24 hours after second dose of amikacin

• Patients reaching target amikacin maximum concentration following third dose

  30 minutes after third dose of amikacin

• Patients reaching target amikacin minimum concentration following third dose

  24 hours after third dose of amikacin

• Time taken to reach recommended Cmax during amikacin therapy

  Maximum 7 days

• Clinical cure test

  At end of treatment (Maximum day 7)

Study Arms (2)

BestDose

EXPERIMENTAL

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Other: Amikacin dose optimization

Control

NO INTERVENTION

Interventions

Amikacin dose optimization OTHER

Therapeutic drug optimization of amikacin using the BestDose software algorithm

BestDose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 34845574 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Claire Roger

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: November 25, 2019
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)