Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department

NCT02365272 | Completed Phase 4

• 1 other identifier: University Hospitals Leuven
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.

Conditions

Sepsis

Keywords

pharmacokinetics; aminoglycosides

Outcome Measures

Primary Outcomes (1)

• Number of participants with amikacin PK/PD target attainment

  The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration \> 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa

  Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Study Arms (2)

amikacin standard dose

ACTIVE COMPARATOR

amikacin in a single standard dose

Drug: Amikacin

amikacin dose for critical care patients

ACTIVE COMPARATOR

amikacin in a single dose for critical care patients

Drug: Amikacin

Interventions

Amikacin DRUG

Amikacin administered in a single dose for critical care patients

amikacin dose for critical care patients; amikacin standard dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied

You may not qualify if:

• \< 18 years
• pregnancy
• burns
• amikacin treatment in the previous 2 weeks
• known allergy to aminoglycosides
• Do Not Reanimate Code ≥ 2
• Hospitalized patients with a prolonged deep venous or arterial catheder
• Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (3)

• Dia N, De Winter S, Gijsen M, Desmet S, Vanbrabant P, Peetermans W, Spriet I, Dreesen E. Dose Optimization of Amikacin in the Emergency Department: A Population Pharmacokinetics Simulation Study. Ther Drug Monit. 2025 Jun 1;47(3):353-362. doi: 10.1097/FTD.0000000000001279. Epub 2024 Dec 3.

  PMID: 40344018 DERIVED

• De Winter S, van Hest R, Dreesen E, Annaert P, Wauters J, Meersseman W, Van den Eede N, Desmet S, Verelst S, Vanbrabant P, Peetermans W, Spriet I. Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):653-663. doi: 10.1007/s13318-021-00698-w. Epub 2021 Jul 23.

  PMID: 34297338 DERIVED

• De Winter S, Wauters J, Meersseman W, Verhaegen J, Van Wijngaerden E, Peetermans W, Annaert P, Verelst S, Spriet I. Higher versus standard amikacin single dose in emergency department patients with severe sepsis and septic shock: a randomised controlled trial. Int J Antimicrob Agents. 2018 Apr;51(4):562-570. doi: 10.1016/j.ijantimicag.2017.11.009. Epub 2017 Nov 24.

  PMID: 29180278 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Amikacin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Sabrina De Winter, PharmD

  KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD - KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 18, 2015
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02