Shock, SepticAMINO BESTDOSENCT04178148
Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
A study testing Amikacin dose optimization in people with Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- Amikacin dose optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2019to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Amikacin dose optimization
- Keywords
- Pharmacokinetics, dose optimisation, aminoglycosides
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amikacin dose optimizationOther
Therapeutic drug optimization of amikacin using the BestDose software algorithm
| Study group | Role | What they receive |
|---|---|---|
| BestDose | Experimental | Therapeutic drug optimization of amikacin using the BestDose software algorithm Receives: Other: Amikacin dose optimization |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients reaching target amikacin maximum concentration following second dose
Yes/no; Cmax 60-80mg/l
Measured: 30 minutes after second dose of amikacin
Secondary outcomes (10)
Patients reaching target amikacin minimum concentration following second dose
Yes/no
Measured: 24 hours after second dose of amikacin
Patients reaching target amikacin maximum concentration following third dose
Yes/no; Cmax 60-80mg/l
Measured: 30 minutes after third dose of amikacin
Patients reaching target amikacin minimum concentration following third dose
Yes/no
Measured: 24 hours after third dose of amikacin
Time taken to reach recommended Cmax during amikacin therapy
Hours
Measured: Maximum 7 days
Clinical cure test
Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Measured: At end of treatment (Maximum day 7)
Clinical cure test
Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Measured: Day 7
Number of days without renal replacement therapy
Number
Measured: Day 28
Number of days without vasopressors
Number
Measured: Day 28
Number of days without mechanical ventilation
Number
Measured: Day 28
Mortality
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start25 Nov 2019
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178148
- Sponsor's protocol ID
- NIMAO/2018-02/CR-01
- Acronym
- AMINO BESTDOSE
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garbez N, Mbatchi LC, Louart G, Wallis SC, Muller L, Lipman J, Roberts JA, Lefrant JY, Roger C. Micafungin Population PK Analysis in Healthy and Septic Pigs: Can the Septic Porcine Model Predict the Micafungin PK in Septic Patients? Pharm Res. 2021 Nov;38(11):1863-1871. doi: 10.1007/s11095-021-03137-2. Epub 2021 Nov 29.
PubMed 34845574
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT04178148
- Acronym / sponsor ID
- AMINO BESTDOSE / NIMAO/2018-02/CR-01
- Conditions
- Shock, Septic
- Keywords
- Pharmacokinetics, dose optimisation, aminoglycosides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BestDose | Experimental | Other: Amikacin dose optimizationTherapeutic drug optimization of amikacin using the BestDose software algorithm |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amikacin dose optimizationTherapeutic drug optimization of amikacin using the BestDose software algorithm | Other | BestDose |
Primary outcome
Patients reaching target amikacin maximum concentration following second dose
Time frame: 30 minutes after second dose of amikacin
Yes/no; Cmax 60-80mg/l
10 secondary outcomes
Patients reaching target amikacin minimum concentration following second dose
Time frame: 24 hours after second dose of amikacin
Patients reaching target amikacin maximum concentration following third dose
Time frame: 30 minutes after third dose of amikacin
Patients reaching target amikacin minimum concentration following third dose
Time frame: 24 hours after third dose of amikacin
Time taken to reach recommended Cmax during amikacin therapy
Time frame: Maximum 7 days
Clinical cure test
Time frame: At end of treatment (Maximum day 7)
Clinical cure test
Time frame: Day 7
Number of days without renal replacement therapy
Time frame: Day 28
Number of days without vasopressors
Time frame: Day 28
Number of days without mechanical ventilation
Time frame: Day 28
Mortality
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 34845574Garbez N, Mbatchi LC, Louart G, Wallis SC, Muller L, Lipman J, Roberts JA, Lefrant JY, Roger C. Micafungin Population PK Analysis in Healthy and Septic Pigs: Can the Septic Porcine Model Predict the Micafungin PK in Septic Patients? Pharm Res. 2021 Nov;38(11):1863-1871. doi: 10.1007/s11095-021-03137-2. Epub 2021 Nov 29.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Roger principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amikacin dose optimization in people with Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients reaching target amikacin maximum concentration following second dose (time frame: 30 minutes after second dose of amikacin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.