NCT03683511

Brief Summary

The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

September 13, 2018

Last Update Submit

September 21, 2018

Conditions

Pharmacokinetics

Keywords

amikacin

Outcome Measures

Primary Outcomes (1)

  • amikacin infusion

    Target is defined as 8 times x Minimal Inhibatory Concentration for MIC = 4 mg/L and MIC = 8 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables.

    one hour after beginning of infusion.ed

Secondary Outcomes (1)

  • maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration.

    24 hours after beginning of infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with amikacin for sepsis ou septic shock in the medical intensive care unit of Nantes,France or in an ICU of Nîmes, France will be recruited.

You may qualify if:

  • patients treated with amikacin for sepsis in one of the participating ICU will be included.

You may not qualify if:

  • patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, France

Location

Related Publications (1)

  • Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1.

    PMID: 26429564BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 25, 2018

Study Start

April 21, 2014

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

FR(1)