Underdosing of AminoglycosidesNCT02850029
An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
An observational study of Underdosing of Aminoglycosides and Critical Illness, run by Centre Hospitalier Universitaire de Nīmes at 85 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Underdosing of Aminoglycosides, Critical Illness
- How many people
- 964 participants
- Where
- 85 sitesin 5 countries
- Study dates
- 21 May 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Large cohort of intensive care units patients receiving aminoglycosides (tobramycin, amikacin or gentamicin) as part of their antimicrobial therapy for sepsis.
Who may be able to join
- 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
Who cannot join
- Aged < 18 years of age
- Previous inclusion in the study
Trial locations and contacts
85 sites in 5 countries.
85 sites in 5 countries
France62 sites
Centre Hospitalier Aix-En-Provence
Aix-en-Provence, 13097
Centre Hospitalier D'Ales
Alès, 30100
Chu Amiens
Amiens, 80054
Chu Angers
Angers, 49100
Chu Angers
Angers, 49933
Centre Hospitalier Arles
Arles, 13637
CHI Robert Ballanger
Aulnay-sous-Bois, 93602
Centre Hospitalier Aurillac
Aurillac, 15000
Centre Hospitalier Avignon
Avignon, 84902
Chru Besancon
Besançon, 25030
Chu Bordeaux
Bordeaux, 33076
Centre Hospitalier de BOULOGNE SUR MER
Boulogne-sur-Mer, 62321
Centre Hospitalier Bourg En Bresse
Bourg-en-Bresse, 01012
Chru Brest
Brest, 29609
Chu Brest- Hopital Cavale
Brest, 29609
CHU CAEN
Caen, 14033
Centre Hospitalier Charleville-Mezieres
Charleville-Mézières, 08011
Chu Clermont-Ferrand
Clermont-Ferrand, 63000
Centre Hospitalier de Compiegne
Compiègne, 60200
Chu Grenoble
Grenoble, 38043
Centre Hospitalier La Rochelle-Hopital Saint Louis
La Rochelle, 17019
Centre Hospitalier du Mans
Le Mans, 72037
Chu Lyon- Hopital La Croix Rousse
Lyon, 69317
Chu Lyon- Lyon Sud
Lyon, 69495
APHM La timone
Marseille, PACA, 13000
Aphm- La Conception
Marseille, 13385
AP-HM - Hopital Nord
Marseille, 13915
Centre Hospitalier Sambre-Avesnois
Maubeuge, 59600
Centre Hospitalier de Montauban
Montauban, 82013
CHU MONTPELLIER-Hopital Lapeyronnie
Montpellier, 34295
CHU MONTPELLIER-Hopital St Eloi
Montpellier, 34295
Centre Hospitalier de MORLAIX
Morlaix, 29672
Chru Nancy -Hopital de Brabois
Nancy, 54511
Chu Nantes- Hopital Hotel Dieu
Nantes, 44035
CHU NANTES- hôpital Nord Laennec
Nantes, 44093
CHU Nice- Hopital Pasteur
Nice, 06001
CHU Nice-Hopital L'Archet
Nice, 06202
Centre Universitaire de Nimes
Nîmes, 30029
AP-HP - Paris St Louis
Paris, 75010
AP-HP - Hopital Paris St Antoine
Paris, 75012
Aphp - Pitie Salpetriere
Paris, 75013
Aphp- Pitie Salpetriere
Paris, 75013
APHP- Bichat
Paris, 75018
APHP- Descartes
Paris, 75908
APHP-Hopital Georges Pompidou
Paris, 75908
AP-HP - Bicetre
Paris, 94275
Centre Hospitalier de PAU
Pau, 64046
Chu Poitiers
Poitiers, 86021
CHU REIMS- Hopital Robert Debré
Reims, 51100
CHU RENNES - Hopital Pontchaillou
Rennes, 35033
Centre Hospitalier de Roanne
Roanne, 42328
Centre Hospitalier de Rodez
Rodez, 12027
CHU ROUEN- Hopital Nicolle
Rouen, 76031
Centre Hospitalier Sainte Catherine
Saint-Brieuc, 22027
CHU La Reunion-Hopital Felix Guyon
Saint-Denis, 97400
CHU SAINT-ETIENNE - Hopital Nord
Saint-Etienne, 42270
Centre Hospitalier de Salon de Provence
Salon-de-Provence, 13658
Centre Hospitalier Sainte Catherine
Saverne, 67703
Centre Hospitalier de Toulon, Hopital Sainte Musse
Toulon, 83056
CHU TOULOUSE- Hopital Rangueil
Toulouse, 31059
Centre Hospitalier Valence
Valence, 26953
Centre Hospitalier de Valenciennes
Valenciennes, 59322
United Kingdom9 sites
Sandwell and west Birmingham hospital
Birmingham
University Hospital Birmingham
Birmingham
Guy'S and St Thomas'
London
Salford royal
Manchester
University Hospital of South Manchester
Manchester
Oxford Radcliffe Hospitals
Oxford
St Helens and Knowsley Hospitals
Prescot
Sheffield Teaching Hospitals
Sheffield
Southampton University Hospitals
Southampton
Australia5 sites
Royal Brisbane Women's Hospital
Brisbane, Queensland, 4029
Royal Brisbane and Women's Hospital
Brisbane
Frankston Hospital Victoria
Frankston
Sunshine Coast hospital
Sunshine Coast
Toowoomba Hospital
Toowoomba
Greece5 sites
Athens Hippocratio Hospital
Athens
Naval and Veterans Hospital of Athens
Athens
University Critical Care Department Aghioi Anargyroi Hospital
Athens
University Hospital of loannina
Ioannina
G. Gennimatas General Hospital
Thessaloniki
Chile4 sites
Hospital Barros Luco Trudeau
Santiago
Hospital CU Chile
Santiago
Salvador Santiago Hospital
Santiago
Hospital Base de Valvidia
Valdivia, Los Ríos Region
About this study
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.
Read the 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.
- Conditions
- Underdosing of Aminoglycosides, Critical Illness
- Being tested
- Observational study, no intervention
- Keywords
- antimicrobial, intensive care units
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aminoglycoside current practices descriptive data in intensive care units
Measured: Seven first days of aminoglycoside therapy
Secondary outcomes (3)
Aminoglycoside dosing regimens
Measured: Seven first days of aminoglycoside therapy
Aminoglycoside therapy duration
Measured: Seven first days of aminoglycoside therapy
Aminoglycoside therapeutic drug monitoring
Measured: Seven first days of aminoglycoside therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start21 May 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Underdosing of AminoglycosidesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850029
- Sponsor's protocol ID
- IRB 15 04 08
- Status last verified
- Jan 2019
- First submitted
- 27 Jul 2016
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33740157
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
- ClinicalTrials.gov ID
- NCT02850029
- Acronym / sponsor ID
- IRB 15 04 08
- Conditions
- Underdosing of Aminoglycosides, Critical Illness
- Keywords
- antimicrobial, intensive care units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 May 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients | – | Other: Observational study, no interventionCritically ill patients admitted in intensive care units and receiving one of the following aminoglycosides: gentamicin, tobramycin and amikacin as part of their usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Large cohort of intensive care units patients receiving aminoglycosides (tobramycin, amikacin or gentamicin) as part of their antimicrobial therapy for sepsis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Aged < 18 years of age
- Previous inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no intervention | Other | critically ill patients |
Primary outcome
Aminoglycoside current practices descriptive data in intensive care units
Time frame: Seven first days of aminoglycoside therapy
3 secondary outcomes
Aminoglycoside dosing regimens
Time frame: Seven first days of aminoglycoside therapy
Aminoglycoside therapy duration
Time frame: Seven first days of aminoglycoside therapy
Aminoglycoside therapeutic drug monitoring
Time frame: Seven first days of aminoglycoside therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 33740157Roger 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Roger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
85 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Underdosing of Aminoglycosides and Critical Illness, run by Centre Hospitalier Universitaire de Nīmes at 85 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in France, United Kingdom, Australia, Greece, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aminoglycoside current practices descriptive data in intensive care units (time frame: Seven first days of aminoglycoside therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02850029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.