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Completed

NCT Number: NCT04178148

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amikacin dose optimization

Other

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Primary outcomes

  1. Patients reaching target amikacin maximum concentration following second dose

    Time frame: 30 minutes after second dose of amikacin

    Yes/no; Cmax 60-80mg/l

Secondary outcomes

  1. Patients reaching target amikacin minimum concentration following second dose

    Time frame: 24 hours after second dose of amikacin

    Yes/no

  2. Patients reaching target amikacin maximum concentration following third dose

    Time frame: 30 minutes after third dose of amikacin

    Yes/no; Cmax 60-80mg/l

  3. Patients reaching target amikacin minimum concentration following third dose

    Time frame: 24 hours after third dose of amikacin

    Yes/no

  4. Time taken to reach recommended Cmax during amikacin therapy

    Time frame: Maximum 7 days

    Hours

  5. Clinical cure test

    Time frame: At end of treatment (Maximum day 7)

    Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed

  6. Clinical cure test

    Time frame: Day 7

    Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed

  7. Number of days without renal replacement therapy

    Time frame: Day 28

    Number

  8. Number of days without vasopressors

    Time frame: Day 28

    Number

  9. Number of days without mechanical ventilation

    Time frame: Day 28

    Number

  10. Mortality

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: AMINO BESTDOSE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2019
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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