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

January 23, 2019 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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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
    • Region DE LOS RIOS
      • Valdivia, Region DE LOS RIOS, Chile
        • Hospital Base de Valvidia
  • France
      • Aix-en-provence, France, 13097
        • Centre Hospitalier Aix-En-Provence
      • Ales, 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-mezieres, France, 08011
        • Centre Hospitalier Charleville-Mezieres
      • Clermont-ferrand, France, 63000
        • CHU Clermont-Ferrand
      • Compiegne, 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
      • Nimes, France, 30029
        • Centre Universitaire de Nimes
      • PAU, France, 64046
        • Centre Hospitalier de Pau
      • Paris, France, 75013
        • APHP - Pitié Salpêtrière
      • 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
      • Poitiers, France, 86021
        • CHU Poitiers
      • Reims, France, 51100
        • CHU REIMS- Hopital Robert Debré
      • Rennes, France, 35033
        • CHU Rennes - Hôpital 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 - Hopital 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- Hopital 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
      • Ioánnina, Greece
        • University Hospital of loannina
      • Thessaloníki, 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

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

Centre Hospitalier Universitaire de Nīmes

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)

May 21, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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