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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

NCT02898961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

30 mg/kg amikacin or 8 mg/kg gentamicin

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02898961 on ClinicalTrials.gov