Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02850029




Registration number
NCT02850029
Ethics application status
Date submitted
27/07/2016
Date registered
29/07/2016
Date last updated
24/01/2019

Titles & IDs
Public title
An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
Scientific title
An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
Secondary ID [1] 0 0
IRB 15 04 08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Underdosing of Aminoglycosides 0 0
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Aminoglycoside current practices descriptive data in intensive care units
Timepoint [1] 0 0
Seven first days of aminoglycoside therapy
Secondary outcome [1] 0 0
Aminoglycoside dosing regimens
Timepoint [1] 0 0
Seven first days of aminoglycoside therapy
Secondary outcome [2] 0 0
Aminoglycoside therapy duration
Timepoint [2] 0 0
Seven first days of aminoglycoside therapy
Secondary outcome [3] 0 0
Aminoglycoside therapeutic drug monitoring
Timepoint [3] 0 0
Seven first days of aminoglycoside therapy

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Aged < 18 years of age
* Previous inclusion in the study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
Accrual to date
Final
964
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Frankston Hospital Victoria - Frankston
Recruitment hospital [4] 0 0
Sunshine Coast hospital - Sunshine Coast
Recruitment hospital [5] 0 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- Sunshine Coast
Recruitment postcode(s) [5] 0 0
- Toowoomba
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Region DE LOS RIOS
Country [2] 0 0
Chile
State/province [2] 0 0
Santiago
Country [3] 0 0
France
State/province [3] 0 0
Paca
Country [4] 0 0
France
State/province [4] 0 0
Aix-en-provence
Country [5] 0 0
France
State/province [5] 0 0
Ales
Country [6] 0 0
France
State/province [6] 0 0
Amiens
Country [7] 0 0
France
State/province [7] 0 0
Angers
Country [8] 0 0
France
State/province [8] 0 0
Arles
Country [9] 0 0
France
State/province [9] 0 0
Aulnay-sous-Bois
Country [10] 0 0
France
State/province [10] 0 0
Aurillac
Country [11] 0 0
France
State/province [11] 0 0
Avignon
Country [12] 0 0
France
State/province [12] 0 0
Besançon
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux
Country [14] 0 0
France
State/province [14] 0 0
Boulogne sur mer
Country [15] 0 0
France
State/province [15] 0 0
Bourg En Bresse
Country [16] 0 0
France
State/province [16] 0 0
Brest
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Charleville-mezieres
Country [19] 0 0
France
State/province [19] 0 0
Clermont-ferrand
Country [20] 0 0
France
State/province [20] 0 0
Compiegne
Country [21] 0 0
France
State/province [21] 0 0
Grenoble
Country [22] 0 0
France
State/province [22] 0 0
La Rochelle
Country [23] 0 0
France
State/province [23] 0 0
Le Mans
Country [24] 0 0
France
State/province [24] 0 0
Lyon
Country [25] 0 0
France
State/province [25] 0 0
Marseille
Country [26] 0 0
France
State/province [26] 0 0
Maubeuge
Country [27] 0 0
France
State/province [27] 0 0
Montauban
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Morlaix
Country [30] 0 0
France
State/province [30] 0 0
Nancy
Country [31] 0 0
France
State/province [31] 0 0
Nantes
Country [32] 0 0
France
State/province [32] 0 0
Nice
Country [33] 0 0
France
State/province [33] 0 0
Nimes
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
PAU
Country [36] 0 0
France
State/province [36] 0 0
Poitiers
Country [37] 0 0
France
State/province [37] 0 0
Reims
Country [38] 0 0
France
State/province [38] 0 0
Rennes
Country [39] 0 0
France
State/province [39] 0 0
Roanne
Country [40] 0 0
France
State/province [40] 0 0
Rodez
Country [41] 0 0
France
State/province [41] 0 0
Rouen
Country [42] 0 0
France
State/province [42] 0 0
Saint Brieuc
Country [43] 0 0
France
State/province [43] 0 0
Saint Denis
Country [44] 0 0
France
State/province [44] 0 0
Saint-etienne
Country [45] 0 0
France
State/province [45] 0 0
Salon de Provence
Country [46] 0 0
France
State/province [46] 0 0
Saverne
Country [47] 0 0
France
State/province [47] 0 0
Toulon
Country [48] 0 0
France
State/province [48] 0 0
Toulouse
Country [49] 0 0
France
State/province [49] 0 0
Valence
Country [50] 0 0
France
State/province [50] 0 0
Valenciennes
Country [51] 0 0
Greece
State/province [51] 0 0
Athens
Country [52] 0 0
Greece
State/province [52] 0 0
Ioánnina
Country [53] 0 0
Greece
State/province [53] 0 0
Thessaloníki
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Birmingham
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Manchester
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Oxford
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Prescot
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Sheffield
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Hospitalier Universitaire de Nimes
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02850029
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claire Roger, MD
Address 0 0
Centre Hospitalier Universitaire de Nîmes
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02850029