NCT02888470

Brief Summary

The aim of the study is to estimate the proportion of intensive care unit patients receiving current aminoglycosides dosing regimens as part of their antibiotic therapy and achieving the recommended maximal plasma concentration (Cmax) after the first and subsequent aminoglycoside doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 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

June 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

June 18, 2026

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 30, 2016

Last Update Submit

June 17, 2026

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Achievement of the recommended Cmax after the first and subsequent aminoglycoside doses.

    7 days

Eligibility Criteria

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

All ICU patients with indication of aminoglycosides (gentamicin, tobramycin or amikacin) for a current infectious episode

You may qualify if:

  • years
  • indication of aminogycoside therapy for a current infectious episode

You may not qualify if:

  • \<18years
  • allergy to aminoglycosides
  • patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 5, 2016

Study Start

June 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 18, 2026

Record last verified: 2016-08

Locations

FR(1)