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NCT04178148: AMINO BESTDOSE
Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
NA trial testing Amikacin dose optimization in Shock, Septic in 180 participants. Completed in 2 December 2022.
2 December 2022
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 180 |
| Start date | 25 November 2019 |
| Primary completion | 2 December 2022 |
| Estimated completion | 2 December 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Amikacin dose optimization
Conditions studied
- Shock, Septic — all drugs for Shock, Septic →
Sponsor
Centre Hospitalier Universitaire de Nīmes
Who can join
18 and older, any sex, with Shock, Septic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04178148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Centre Hospitalier Universitaire de Nīmes trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04178148 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes
- Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04178148.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing