Clinical trial NCT02850029: An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
Official title: An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Underdosing of Aminoglycosides
Critical Illness
Keywords: antimicrobial
intensive care units
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 964
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aminoglycoside current practices descriptive data in intensive care units
timeFrame: Seven first days of aminoglycoside therapy
Secondary outcomes:
measure: Aminoglycoside dosing regimens
timeFrame: Seven first days of aminoglycoside therapy
measure: Aminoglycoside therapy duration
timeFrame: Seven first days of aminoglycoside therapy
measure: Aminoglycoside therapeutic drug monitoring
timeFrame: Seven first days of aminoglycoside therapy
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Frankston
country: Australia
facility: Frankston Hospital Victoria
city: Sunshine Coast
country: Australia
facility: Sunshine Coast hospital
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
city: Valdivia
country: Chile
facility: Hospital Base de Valvidia
state: Region DE LOS RIOS
city: Santiago
country: Chile
facility: Hospital Barros Luco Trudeau
city: Santiago
country: Chile
facility: Hospital CU Chile
city: Santiago
country: Chile
facility: Salvador Santiago Hospital
city: Marseille
country: France
facility: APHM La timone
state: Paca
city: Aix-en-provence
country: France
facility: Centre Hospitalier Aix-En-Provence
city: Ales
country: France
facility: Centre Hospitalier D'Ales
city: Amiens
country: France
facility: Chu Amiens
city: Angers
country: France
facility: Chu Angers
city: Angers
country: France
facility: Chu Angers
city: Arles
country: France
facility: Centre Hospitalier Arles
city: Aulnay-sous-Bois
country: France
facility: CHI Robert Ballanger
city: Aurillac
country: France
facility: Centre Hospitalier Aurillac
city: Avignon
country: France
facility: Centre Hospitalier Avignon
city: Besançon
country: France
facility: Chru Besancon
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Boulogne sur mer
country: France
facility: Centre Hospitalier de BOULOGNE SUR MER
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Bourg En Bresse
city: Brest
country: France
facility: Chru Brest
city: Brest
country: France
facility: Chu Brest- Hopital Cavale
city: Caen
country: France
facility: CHU CAEN
city: Charleville-mezieres
country: France
facility: Centre Hospitalier Charleville-Mezieres
city: Clermont-ferrand
country: France
facility: Chu Clermont-Ferrand
city: Compiegne
country: France
facility: Centre Hospitalier de Compiegne
city: Grenoble
country: France
facility: Chu Grenoble
city: La Rochelle
country: France
facility: Centre Hospitalier La Rochelle-Hopital Saint Louis
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lyon
country: France
facility: Chu Lyon- Hopital La Croix Rousse
city: Lyon
country: France
facility: Chu Lyon- Lyon Sud
city: Marseille
country: France
facility: Aphm- La Conception
city: Marseille
country: France
facility: AP-HM - Hopital Nord
city: Maubeuge
country: France
facility: Centre Hospitalier Sambre-Avesnois
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Montpellier
country: France
facility: CHU MONTPELLIER-Hopital Lapeyronnie
city: Montpellier
country: France
facility: CHU MONTPELLIER-Hopital St Eloi
city: Morlaix
country: France
facility: Centre Hospitalier de MORLAIX
city: Nancy
country: France
facility: Chru Nancy -Hopital de Brabois
city: Nantes
country: France
facility: Chu Nantes- Hopital Hotel Dieu
city: Nantes
country: France
facility: CHU NANTES- hôpital Nord Laennec
city: Nice
country: France
facility: CHU Nice- Hopital Pasteur
city: Nice
country: France
facility: CHU Nice-Hopital L'Archet
city: Nimes
country: France
facility: Centre Universitaire de Nimes
city: Paris
country: France
facility: AP-HP - Paris St Louis
city: Paris
country: France
facility: AP-HP - Hopital Paris St Antoine
city: Paris
country: France
facility: Aphp - Pitie Salpetriere
city: Paris
country: France
facility: Aphp- Pitie Salpetriere
city: Paris
country: France
facility: APHP- Bichat
city: Paris
country: France
facility: APHP- Descartes
city: Paris
country: France
facility: APHP-Hopital Georges Pompidou
city: Paris
country: France
facility: AP-HP - Bicetre
city: PAU
country: France
facility: Centre Hospitalier de PAU
city: Poitiers
country: France
facility: Chu Poitiers
city: Reims
country: France
facility: CHU REIMS- Hopital Robert Debré
city: Rennes
country: France
facility: CHU RENNES - Hopital Pontchaillou
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
city: Rouen
country: France
facility: CHU ROUEN- Hopital Nicolle
city: Saint Brieuc
country: France
facility: Centre Hospitalier Sainte Catherine
city: Saint Denis
country: France
facility: CHU La Reunion-Hopital Felix Guyon
city: Saint-etienne
country: France
facility: CHU SAINT-ETIENNE - Hopital Nord
city: Salon de Provence
country: France
facility: Centre Hospitalier de Salon de Provence
city: Saverne
country: France
facility: Centre Hospitalier Sainte Catherine
city: Toulon
country: France
facility: Centre Hospitalier de Toulon, Hopital Sainte Musse
city: Toulouse
country: France
facility: CHU TOULOUSE- Hopital Rangueil
city: Valence
country: France
facility: Centre Hospitalier Valence
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
city: Athens
country: Greece
facility: Athens Hippocratio Hospital
city: Athens
country: Greece
facility: Naval and Veterans Hospital of Athens
city: Athens
country: Greece
facility: University Critical Care Department Aghioi Anargyroi Hospital
city: Ioánnina
country: Greece
facility: University Hospital of loannina
city: Thessaloníki
country: Greece
facility: G. Gennimatas General Hospital
city: Birmingham
country: United Kingdom
facility: Sandwell and west Birmingham hospital
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: London
country: United Kingdom
facility: Guy'S and St Thomas'
city: Manchester
country: United Kingdom
facility: Salford royal
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospitals
city: Prescot
country: United Kingdom
facility: St Helens and Knowsley Hospitals
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Claire Roger, MD
role: PRINCIPAL_INVESTIGATOR
References: