Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis
Aminoside_II
1 other identifier
interventional
63
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 sepsis
Started Oct 2014
Typical duration for phase_4 sepsis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedNovember 21, 2025
December 1, 2020
2.3 years
September 1, 2016
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Presence/absence of target peak serum concentration of aminosides
Achievement of targeted peak serum concentration?
30 minutes after the end of the infusion.
Study Arms (1)
The study population
EXPERIMENTALICU patients with severe sepsis treated with aminoglycosides were recruited. Intervention: 30 mg/kg amikacin or 8 mg/kg gentamicin
Interventions
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.
Eligibility Criteria
You may qualify if:
- ICU patient with severe sepsis
- Treated with aminoglycosides
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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: 26429564RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2016
First Posted
September 13, 2016
Study Start
October 1, 2014
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
November 21, 2025
Record last verified: 2020-12