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

Primary Purpose

Shock, Septic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Amikacin dose optimization
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shock, Septic focused on measuring Pharmacokinetics, dose optimisation, aminoglycosides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nimes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BestDose

Control

Arm Description

Therapeutic drug optimization of amikacin using the BestDose software algorithm

Outcomes

Primary Outcome Measures

Patients reaching target amikacin maximum concentration following second dose
Yes/no; Cmax 60-80mg/l

Secondary Outcome Measures

Patients reaching target amikacin minimum concentration following second dose
Yes/no
Patients reaching target amikacin maximum concentration following third dose
Yes/no; Cmax 60-80mg/l
Patients reaching target amikacin minimum concentration following third dose
Yes/no
Time taken to reach recommended Cmax during amikacin therapy
Hours
Clinical cure test
Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Clinical cure test
Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Number of days without renal replacement therapy
Number
Number of days without vasopressors
Number
Number of days without mechanical ventilation
Number
Mortality

Full Information

First Posted
November 22, 2019
Last Updated
April 3, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04178148
Brief Title
Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
Acronym
AMINO BESTDOSE
Official Title
Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
December 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic
Keywords
Pharmacokinetics, dose optimisation, aminoglycosides

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BestDose
Arm Type
Experimental
Arm Description
Therapeutic drug optimization of amikacin using the BestDose software algorithm
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Amikacin dose optimization
Intervention Description
Therapeutic drug optimization of amikacin using the BestDose software algorithm
Primary Outcome Measure Information:
Title
Patients reaching target amikacin maximum concentration following second dose
Description
Yes/no; Cmax 60-80mg/l
Time Frame
30 minutes after second dose of amikacin
Secondary Outcome Measure Information:
Title
Patients reaching target amikacin minimum concentration following second dose
Description
Yes/no
Time Frame
24 hours after second dose of amikacin
Title
Patients reaching target amikacin maximum concentration following third dose
Description
Yes/no; Cmax 60-80mg/l
Time Frame
30 minutes after third dose of amikacin
Title
Patients reaching target amikacin minimum concentration following third dose
Description
Yes/no
Time Frame
24 hours after third dose of amikacin
Title
Time taken to reach recommended Cmax during amikacin therapy
Description
Hours
Time Frame
Maximum 7 days
Title
Clinical cure test
Description
Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Time Frame
At end of treatment (Maximum day 7)
Title
Clinical cure test
Description
Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Time Frame
Day 7
Title
Number of days without renal replacement therapy
Description
Number
Time Frame
Day 28
Title
Number of days without vasopressors
Description
Number
Time Frame
Day 28
Title
Number of days without mechanical ventilation
Description
Number
Time Frame
Day 28
Title
Mortality
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Roger
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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