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Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis (Aminoside_II)

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
30 mg/kg amikacin or 8 mg/kg gentamicin
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ICU patient with severe sepsis
  • Treated with aminoglycosides

Exclusion Criteria:

  • Renal replacement therapy
  • Allergy to aminoglycosides
  • Confirmed and/or suspected to have myasthenia
  • ICU-acquired neuromuscular disorder
  • Under guardianship
  • Prisoners
  • The patient has already participated in the present protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    The study population

    Arm Description

    ICU patients with severe sepsis treated with aminoglycosides were recruited. Intervention: 30 mg/kg amikacin or 8 mg/kg gentamicin

    Outcomes

    Primary Outcome Measures

    Presence/absence of target peak serum concentration of aminosides
    Achievement of targeted peak serum concentration?

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2016
    Last Updated
    December 17, 2020
    Sponsor
    Centre Hospitalier Universitaire de Nīmes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02898961
    Brief Title
    Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis
    Acronym
    Aminoside_II
    Official Title
    Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (Actual)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nīmes

    4. Oversight

    5. Study Description

    Brief Summary
    Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in ICU patients with severe sepsis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The study population
    Arm Type
    Experimental
    Arm Description
    ICU patients with severe sepsis treated with aminoglycosides were recruited. Intervention: 30 mg/kg amikacin or 8 mg/kg gentamicin
    Intervention Type
    Drug
    Intervention Name(s)
    30 mg/kg amikacin or 8 mg/kg gentamicin
    Intervention Description
    In order to improve the achievement of target peak concentrations, either 30 mg/kg amikacin or 8 mg/kg gentamicin was prescribed in ICU patients with severe sepsis. In combination with broad-spectrum antibiotics, according to the suspected pathogens and local clinical practice, 30 mg/kg amikacin or 8 mg/kg gentamicin was given (30 min intravenous infusion; the dosage ampoule was systematically emptied with a 5 ml flush). The peak serum concentration sampling occurred 30 minutes after the end of the infusion.
    Primary Outcome Measure Information:
    Title
    Presence/absence of target peak serum concentration of aminosides
    Description
    Achievement of targeted peak serum concentration?
    Time Frame
    30 minutes after the end of the infusion.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ICU patient with severe sepsis Treated with aminoglycosides Exclusion Criteria: Renal replacement therapy Allergy to aminoglycosides Confirmed and/or suspected to have myasthenia ICU-acquired neuromuscular disorder Under guardianship Prisoners The patient has already participated in the present protocol

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26429564
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    https://doi.org/10.1093/jac/dkv291
    Description
    Publication Website

    Learn more about this trial

    Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis

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