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

Shock, Septic Clinical Trial

— AMINO BESTDOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178148
• Other study ID #: NIMAO/2018-02/CR-01
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: December 2, 2022

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

Other:
• Amikacin dose optimization
Therapeutic drug optimization of amikacin using the BestDose software algorithm

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients reaching target amikacin maximum concentration following second dose	Yes/no; Cmax 60-80mg/l	30 minutes after second dose of amikacin
Secondary	Patients reaching target amikacin minimum concentration following second dose	Yes/no	24 hours after second dose of amikacin
Secondary	Patients reaching target amikacin maximum concentration following third dose	Yes/no; Cmax 60-80mg/l	30 minutes after third dose of amikacin
Secondary	Patients reaching target amikacin minimum concentration following third dose	Yes/no	24 hours after third dose of amikacin
Secondary	Time taken to reach recommended Cmax during amikacin therapy	Hours	Maximum 7 days
Secondary	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)
Secondary	Clinical cure test	Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed	Day 7
Secondary	Number of days without renal replacement therapy	Number	Day 28
Secondary	Number of days without vasopressors	Number	Day 28
Secondary	Number of days without mechanical ventilation	Number	Day 28
Secondary	Mortality		Day 28