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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BestDose | Experimental | Therapeutic drug optimization of amikacin using the BestDose software algorithm |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amikacin dose optimization | Other | Therapeutic drug optimization of amikacin using the BestDose software algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients reaching target amikacin maximum concentration following second dose | Yes/no; Cmax 60-80mg/l | 30 minutes after second dose of amikacin |
| Measure | Description | Time Frame |
|---|---|---|
| Patients reaching target amikacin minimum concentration following second dose | Yes/no | 24 hours after second dose of amikacin |
| Patients reaching target amikacin maximum concentration following third dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Roger | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34845574 | Result | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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Yes/no; Cmax 60-80mg/l
| 30 minutes after third dose of amikacin |
| Patients reaching target amikacin minimum concentration following third dose | Yes/no | 24 hours after third dose of amikacin |
| Time taken to reach recommended Cmax during amikacin therapy | Hours | Maximum 7 days |
| 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) |
| Clinical cure test | Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed | Day 7 |
| Number of days without renal replacement therapy | Number | Day 28 |
| Number of days without vasopressors | Number | Day 28 |
| Number of days without mechanical ventilation | Number | Day 28 |
| Mortality | Day 28 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |