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

NCT04178148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-10

No results posted yet for this study

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

Interventions

OTHER

Amikacin dose optimization

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Claire Roger · CHU Nimes

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2022-12-02
Completion
2022-12-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178148 on ClinicalTrials.gov