An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey

November 18, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
This is an international observational cohort study on current aminoglycoside practices in intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring data will be collected during the first week of aminoglycoside (tobramycin, amikacin or gentamicin) administration in different countries over a year. A minimum of ten consecutive patients will be enrolled at each site.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aminoglycosides are commonly used antibiotics for difficult to treat infections. However, aminoglycoside administration varies widely among countries. The aim of this multicenter observational study is to provide up-to-date and comprehensive descriptive data on current aminoglycoside (tobramycin, amikacin or gentamicin) use in a large cohort of critically ill patients in different countries. The benefits expected from this study are a better understanding of worldwide aminoglycoside prescription variability in critically ill patients and to determine the risk factors of inadequate aminoglycoside dosing regimens.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
964

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • Royal Brisbane and Women's Hospital
      • Frankston, Australia
        • Frankston Hospital Victoria
      • Sunshine Coast, Australia
        • Sunshine Coast hospital
      • Toowoomba, Australia
        • Toowoomba Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane Women's Hospital
  • Chile
      • Santiago, Chile
        • Hospital Barros Luco Trudeau
      • Santiago, Chile
        • Hospital CU Chile
      • Santiago, Chile
        • Salvador Santiago Hospital
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile
        • Hospital Base de Valvidia
  • France
      • Aix-en-Provence, France, 13097
        • Centre Hospitalier Aix-En-Provence
      • Alès, France, 30100
        • Centre Hospitalier d'Alès
      • Amiens, France, 80054
        • CHU Amiens
      • Angers, France, 49933
        • CHU Angers
      • Angers, France, 49100
        • CHU Angers
      • Arles, France, 13637
        • Centre Hospitalier Arles
      • Aulnay-sous-Bois, France, 93602
        • CHI Robert Ballanger
      • Aurillac, France, 15000
        • Centre Hospitalier Aurillac
      • Avignon, France, 84902
        • Centre Hospitalier Avignon
      • Besançon, France, 25030
        • CHRU Besançon
      • Bordeaux, France, 33076
        • CHU Bordeaux
      • Boulogne-sur-Mer, France, 62321
        • Centre Hospitalier de Boulogne Sur Mer
      • Bourg-en-Bresse, France, 01012
        • Centre Hospitalier Bourg En Bresse
      • Brest, France, 29609
        • CHRU Brest
      • Brest, France, 29609
        • Chu Brest- Hopital Cavale
      • Caen, France, 14033
        • CHU Caen
      • Charleville-Mézières, France, 08011
        • Centre Hospitalier Charleville-Mezieres
      • Clermont-Ferrand, France, 63000
        • CHU Clermont-Ferrand
      • Compiègne, France, 60200
        • Centre Hospitalier de Compiegne
      • Grenoble, France, 38043
        • CHU Grenoble
      • La Rochelle, France, 17019
        • Centre Hospitalier La Rochelle-Hopital Saint Louis
      • Le Mans, France, 72037
        • Centre Hospitalier Du Mans
      • Lyon, France, 69317
        • Chu Lyon- Hopital La Croix Rousse
      • Lyon, France, 69495
        • Chu Lyon- Lyon Sud
      • Marseille, France, 13915
        • AP-HM - Hôpital Nord
      • Marseille, France, 13385
        • Aphm- La Conception
      • Maubeuge, France, 59600
        • Centre Hospitalier Sambre-Avesnois
      • Montauban, France, 82013
        • Centre Hospitalier de Montauban
      • Montpellier, France, 34295
        • CHU MONTPELLIER-Hopital Lapeyronnie
      • Montpellier, France, 34295
        • CHU MONTPELLIER-Hopital St Eloi
      • Morlaix, France, 29672
        • Centre Hospitalier de Morlaix
      • Nancy, France, 54511
        • Chru Nancy -Hopital de Brabois
      • Nantes, France, 44035
        • Chu Nantes- Hopital Hotel Dieu
      • Nantes, France, 44093
        • CHU NANTES- hôpital Nord Laennec
      • Nice, France, 06001
        • CHU Nice- Hopital Pasteur
      • Nice, France, 06202
        • CHU Nice-Hôpital l'Archet
      • Nîmes, France, 30029
        • Centre Universitaire de Nimes
      • Paris, France, 75013
        • Aphp - Pitie Salpetriere
      • Paris, France, 75010
        • AP-HP - Paris St Louis
      • Paris, France, 75012
        • AP-HP - Hopital Paris St Antoine
      • Paris, France, 75013
        • Aphp- Pitie Salpetriere
      • Paris, France, 75018
        • APHP- Bichat
      • Paris, France, 75908
        • APHP- Descartes
      • Paris, France, 75908
        • APHP-Hopital Georges Pompidou
      • Paris, France, 94275
        • AP-HP - Bicetre
      • Pau, France, 64046
        • Centre Hospitalier de Pau
      • Poitiers, France, 86021
        • CHU Poitiers
      • Reims, France, 51100
        • CHU REIMS- Hopital Robert Debré
      • Rennes, France, 35033
        • CHU Rennes - Hopital Pontchaillou
      • Roanne, France, 42328
        • Centre hospitalier de Roanne
      • Rodez, France, 12027
        • Centre Hospitalier de Rodez
      • Rouen, France, 76031
        • CHU ROUEN- Hopital Nicolle
      • Saint-Brieuc, France, 22027
        • Centre Hospitalier Sainte Catherine
      • Saint-Denis, France, 97400
        • CHU La Reunion-Hopital Felix Guyon
      • Saint-Etienne, France, 42270
        • CHU Saint-Etienne - Hôpital Nord
      • Salon-de-Provence, France, 13658
        • Centre Hospitalier de Salon de Provence
      • Saverne, France, 67703
        • Centre Hospitalier Sainte Catherine
      • Toulon, France, 83056
        • Centre Hospitalier de Toulon, Hopital Sainte Musse
      • Toulouse, France, 31059
        • CHU TOULOUSE- Hôpital Rangueil
      • Valence, France, 26953
        • Centre Hospitalier Valence
      • Valenciennes, France, 59322
        • Centre Hospitalier de Valenciennes
    • PACA
      • Marseille, PACA, France, 13000
        • APHM La Timone
  • Greece
      • Athens, Greece
        • Athens Hippocratio Hospital
      • Athens, Greece
        • Naval and Veterans Hospital of Athens
      • Athens, Greece
        • University Critical Care Department Aghioi Anargyroi Hospital
      • Ioannina, Greece
        • University Hospital of loannina
      • Thessaloniki, Greece
        • G. Gennimatas General Hospital
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospital Birmingham
      • Birmingham, United Kingdom
        • Sandwell and west Birmingham hospital
      • London, United Kingdom
        • Guy's and St Thomas'
      • Manchester, United Kingdom
        • University Hospital of South Manchester
      • Manchester, United Kingdom
        • Salford Royal
      • Oxford, United Kingdom
        • Oxford Radcliffe Hospitals
      • Prescot, United Kingdom
        • St Helens and Knowsley Hospitals
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals
      • Southampton, United Kingdom
        • Southampton University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Large cohort of intensive care units patients receiving aminoglycosides (tobramycin, amikacin or gentamicin) as part of their antimicrobial therapy for sepsis.

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Intensive care unit patients
  • Receiving aminoglycoside therapy for a sepsis according to the Third International Consensus Definitions for Sepsis and Septic Shock

Exclusion Criteria:

  • Aged < 18 years of age
  • Previous inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
critically ill patients
Critically ill patients admitted in intensive care units and receiving one of the following aminoglycosides: gentamicin, tobramycin and amikacin as part of their usual care.
Other: Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Aminoglycoside current practices descriptive data in intensive care units
Time Frame: Seven first days of aminoglycoside therapy
Seven first days of aminoglycoside therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Aminoglycoside dosing regimens
Time Frame: Seven first days of aminoglycoside therapy
Seven first days of aminoglycoside therapy
Aminoglycoside therapy duration
Time Frame: Seven first days of aminoglycoside therapy
Seven first days of aminoglycoside therapy
Aminoglycoside therapeutic drug monitoring
Time Frame: Seven first days of aminoglycoside therapy
Seven first days of aminoglycoside therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claire Roger, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 15 04 08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings