NCT02850029

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
964

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
5 countries

85 active sites

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

May 21, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

November 21, 2025

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

July 27, 2016

Last Update Submit

November 18, 2025

Conditions

Keywords

antimicrobialintensive care units

Outcome Measures

Primary Outcomes (1)

  • Aminoglycoside current practices descriptive data in intensive care units

    Seven first days of aminoglycoside therapy

Secondary Outcomes (3)

  • Aminoglycoside dosing regimens

    Seven first days of aminoglycoside therapy

  • Aminoglycoside therapy duration

    Seven first days of aminoglycoside therapy

  • Aminoglycoside therapeutic drug monitoring

    Seven first days of aminoglycoside therapy

Study Arms (1)

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

Interventions

critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Aged \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (85)

Royal Brisbane Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Australia

Location

Frankston Hospital Victoria

Frankston, Australia

Location

Sunshine Coast hospital

Sunshine Coast, Australia

Location

Toowoomba Hospital

Toowoomba, Australia

Location

Hospital Base de Valvidia

Valdivia, Los Ríos Region, Chile

Location

Hospital Barros Luco Trudeau

Santiago, Chile

Location

Hospital CU Chile

Santiago, Chile

Location

Salvador Santiago Hospital

Santiago, Chile

Location

APHM La timone

Marseille, PACA, 13000, France

Location

Centre Hospitalier Aix-En-Provence

Aix-en-Provence, 13097, France

Location

Centre Hospitalier D'Ales

Alès, 30100, France

Location

Chu Amiens

Amiens, 80054, France

Location

Chu Angers

Angers, 49100, France

Location

Chu Angers

Angers, 49933, France

Location

Centre Hospitalier Arles

Arles, 13637, France

Location

CHI Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Centre Hospitalier Aurillac

Aurillac, 15000, France

Location

Centre Hospitalier Avignon

Avignon, 84902, France

Location

Chru Besancon

Besançon, 25030, France

Location

Chu Bordeaux

Bordeaux, 33076, France

Location

Centre Hospitalier de BOULOGNE SUR MER

Boulogne-sur-Mer, 62321, France

Location

Centre Hospitalier Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Chru Brest

Brest, 29609, France

Location

Chu Brest- Hopital Cavale

Brest, 29609, France

Location

CHU CAEN

Caen, 14033, France

Location

Centre Hospitalier Charleville-Mezieres

Charleville-Mézières, 08011, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier de Compiegne

Compiègne, 60200, France

Location

Chu Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier La Rochelle-Hopital Saint Louis

La Rochelle, 17019, France

Location

Centre Hospitalier du Mans

Le Mans, 72037, France

Location

Chu Lyon- Hopital La Croix Rousse

Lyon, 69317, France

Location

Chu Lyon- Lyon Sud

Lyon, 69495, France

Location

Aphm- La Conception

Marseille, 13385, France

Location

AP-HM - Hopital Nord

Marseille, 13915, France

Location

Centre Hospitalier Sambre-Avesnois

Maubeuge, 59600, France

Location

Centre Hospitalier de Montauban

Montauban, 82013, France

Location

CHU MONTPELLIER-Hopital Lapeyronnie

Montpellier, 34295, France

Location

CHU MONTPELLIER-Hopital St Eloi

Montpellier, 34295, France

Location

Centre Hospitalier de MORLAIX

Morlaix, 29672, France

Location

Chru Nancy -Hopital de Brabois

Nancy, 54511, France

Location

Chu Nantes- Hopital Hotel Dieu

Nantes, 44035, France

Location

CHU NANTES- hôpital Nord Laennec

Nantes, 44093, France

Location

CHU Nice- Hopital Pasteur

Nice, 06001, France

Location

CHU Nice-Hopital L'Archet

Nice, 06202, France

Location

Centre Universitaire de Nimes

Nîmes, 30029, France

Location

AP-HP - Paris St Louis

Paris, 75010, France

Location

AP-HP - Hopital Paris St Antoine

Paris, 75012, France

Location

Aphp - Pitie Salpetriere

Paris, 75013, France

Location

Aphp- Pitie Salpetriere

Paris, 75013, France

Location

APHP- Bichat

Paris, 75018, France

Location

APHP- Descartes

Paris, 75908, France

Location

APHP-Hopital Georges Pompidou

Paris, 75908, France

Location

AP-HP - Bicetre

Paris, 94275, France

Location

Centre Hospitalier de PAU

Pau, 64046, France

Location

Chu Poitiers

Poitiers, 86021, France

Location

CHU REIMS- Hopital Robert Debré

Reims, 51100, France

Location

CHU RENNES - Hopital Pontchaillou

Rennes, 35033, France

Location

Centre Hospitalier de Roanne

Roanne, 42328, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

CHU ROUEN- Hopital Nicolle

Rouen, 76031, France

Location

Centre Hospitalier Sainte Catherine

Saint-Brieuc, 22027, France

Location

CHU La Reunion-Hopital Felix Guyon

Saint-Denis, 97400, France

Location

CHU SAINT-ETIENNE - Hopital Nord

Saint-Etienne, 42270, France

Location

Centre Hospitalier de Salon de Provence

Salon-de-Provence, 13658, France

Location

Centre Hospitalier Sainte Catherine

Saverne, 67703, France

Location

Centre Hospitalier de Toulon, Hopital Sainte Musse

Toulon, 83056, France

Location

CHU TOULOUSE- Hopital Rangueil

Toulouse, 31059, France

Location

Centre Hospitalier Valence

Valence, 26953, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59322, France

Location

Athens Hippocratio Hospital

Athens, Greece

Location

Naval and Veterans Hospital of Athens

Athens, Greece

Location

University Critical Care Department Aghioi Anargyroi Hospital

Athens, Greece

Location

University Hospital of loannina

Ioannina, Greece

Location

G. Gennimatas General Hospital

Thessaloniki, Greece

Location

Sandwell and west Birmingham hospital

Birmingham, United Kingdom

Location

University Hospital Birmingham

Birmingham, United Kingdom

Location

Guy'S and St Thomas'

London, United Kingdom

Location

Salford royal

Manchester, United Kingdom

Location

University Hospital of South Manchester

Manchester, United Kingdom

Location

Oxford Radcliffe Hospitals

Oxford, United Kingdom

Location

St Helens and Knowsley Hospitals

Prescot, United Kingdom

Location

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Location

Southampton University Hospitals

Southampton, United Kingdom

Location

Related Publications (1)

  • Roger C, Louart B, Elotmani L, Barton G, Escobar L, Koulenti D, Lipman J, Leone M, Muller L, Boutin C, Amour J, Banakh I, Cousson J, Bourenne J, Constantin JM, Albanese J, Roberts JA, Lefrant JY; Azurea Network. An international survey on aminoglycoside practices in critically ill patients: the AMINO III study. Ann Intensive Care. 2021 Mar 19;11(1):49. doi: 10.1186/s13613-021-00834-4.

MeSH Terms

Conditions

Critical Illness

Interventions

Observation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Claire Roger, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

May 21, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

November 21, 2025

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations