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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04178148
• Collaborator: (none)
• Enrollment: 260
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.2
• Patients Per Site Per Month: 8.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shock, Septic	Other: Amikacin dose optimization	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
• Actual Study Start Date: Nov 25, 2019
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BestDose Therapeutic drug optimization of amikacin using the BestDose software algorithm	Other: Amikacin dose optimization; Therapeutic drug optimization of amikacin using the BestDose software algorithm
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Patients reaching target amikacin maximum concentration following second dose [30 minutes after second dose of amikacin]

   Yes/no; Cmax 60-80mg/l

Secondary Outcome Measures

1. Patients reaching target amikacin minimum concentration following second dose [24 hours after second dose of amikacin]

   Yes/no

2. Patients reaching target amikacin maximum concentration following third dose [30 minutes after third dose of amikacin]

   Yes/no; Cmax 60-80mg/l

3. Patients reaching target amikacin minimum concentration following third dose [24 hours after third dose of amikacin]

   Yes/no

4. Time taken to reach recommended Cmax during amikacin therapy [Maximum 7 days]

   Hours

5. Clinical cure test [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 [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 [Day 28]

   Number

8. Number of days without vasopressors [Day 28]

   Number

9. Number of days without mechanical ventilation [Day 28]

   Number

10. Mortality [Day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nimes	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Claire Roger, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT04178148
• Other Study ID Numbers: NIMAO/2018-02/CR-01
• First Posted: Nov 26, 2019
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Nīmes: Pharmacokinetics; dose optimisation; aminoglycosides
• Additional relevant MeSH terms: Shock, Septic; Shock; Amikacin

Study Results

No Results Posted as of Aug 5, 2021