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
About this trial
This is an interventional treatment trial for Sepsis
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
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
NCT ID
NCT02898961
First Posted
September 1, 2016
Last Updated
December 17, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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
We'll reach out to this number within 24 hrs