Critical Illness Clinical Trial
Official title:
An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey
| NCT number | NCT02850029 |
| Other study ID # | IRB 15 04 08 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 21, 2016 |
| Est. completion date | December 31, 2017 |
| Verified date | January 2019 |
| Source | Centre Hospitalier Universitaire de Nimes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 964 |
| Est. completion date | December 31, 2017 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Brisbane and Women's Hospital | Brisbane | |
| Australia | Royal Brisbane Women's Hospital | Brisbane | Queensland |
| Australia | Frankston Hospital Victoria | Frankston | |
| Australia | Sunshine Coast hospital | Sunshine Coast | |
| Australia | Toowoomba Hospital | Toowoomba | |
| Chile | Hospital Barros Luco Trudeau | Santiago | |
| Chile | Hospital CU Chile | Santiago | |
| Chile | Salvador Santiago Hospital | Santiago | |
| Chile | Hospital Base de Valvidia | Valdivia | Region DE LOS RIOS |
| France | Centre Hospitalier Aix-En-Provence | Aix-en-provence | |
| France | Centre Hospitalier D'Ales | Ales | |
| France | Chu Amiens | Amiens | |
| France | Chu Angers | Angers | |
| France | Chu Angers | Angers | |
| France | Centre Hospitalier Arles | Arles | |
| France | CHI Robert Ballanger | Aulnay-sous-Bois | |
| France | Centre Hospitalier Aurillac | Aurillac | |
| France | Centre Hospitalier Avignon | Avignon | |
| France | Chru Besancon | Besançon | |
| France | Chu Bordeaux | Bordeaux | |
| France | Centre Hospitalier de BOULOGNE SUR MER | Boulogne sur mer | |
| France | Centre Hospitalier Bourg En Bresse | Bourg En Bresse | |
| France | Chru Brest | Brest | |
| France | Chu Brest- Hopital Cavale | Brest | |
| France | CHU CAEN | Caen | |
| France | Centre Hospitalier Charleville-Mezieres | Charleville-mezieres | |
| France | Chu Clermont-Ferrand | Clermont-ferrand | |
| France | Centre Hospitalier de Compiegne | Compiegne | |
| France | Chu Grenoble | Grenoble | |
| France | Centre Hospitalier La Rochelle-Hopital Saint Louis | La Rochelle | |
| France | Centre Hospitalier du Mans | Le Mans | |
| France | Chu Lyon- Hopital La Croix Rousse | Lyon | |
| France | Chu Lyon- Lyon Sud | Lyon | |
| France | AP-HM - Hopital Nord | Marseille | |
| France | APHM La timone | Marseille | Paca |
| France | Aphm- La Conception | Marseille | |
| France | Centre Hospitalier Sambre-Avesnois | Maubeuge | |
| France | Centre Hospitalier de Montauban | Montauban | |
| France | CHU MONTPELLIER-Hopital Lapeyronnie | Montpellier | |
| France | CHU MONTPELLIER-Hopital St Eloi | Montpellier | |
| France | Centre Hospitalier de MORLAIX | Morlaix | |
| France | Chru Nancy -Hopital de Brabois | Nancy | |
| France | Chu Nantes- Hopital Hotel Dieu | Nantes | |
| France | CHU NANTES- hôpital Nord Laennec | Nantes | |
| France | CHU Nice- Hopital Pasteur | Nice | |
| France | CHU Nice-Hopital L'Archet | Nice | |
| France | Centre Universitaire de Nimes | Nimes | |
| France | AP-HP - Bicetre | Paris | |
| France | AP-HP - Hopital Paris St Antoine | Paris | |
| France | AP-HP - Paris St Louis | Paris | |
| France | Aphp - Pitie Salpetriere | Paris | |
| France | APHP- Bichat | Paris | |
| France | APHP- Descartes | Paris | |
| France | Aphp- Pitie Salpetriere | Paris | |
| France | APHP-Hopital Georges Pompidou | Paris | |
| France | Centre Hospitalier de PAU | PAU | |
| France | Chu Poitiers | Poitiers | |
| France | CHU REIMS- Hopital Robert Debré | Reims | |
| France | CHU RENNES - Hopital Pontchaillou | Rennes | |
| France | Centre Hospitalier de Roanne | Roanne | |
| France | Centre Hospitalier de Rodez | Rodez | |
| France | CHU ROUEN- Hopital Nicolle | Rouen | |
| France | Centre Hospitalier Sainte Catherine | Saint Brieuc | |
| France | CHU La Reunion-Hopital Felix Guyon | Saint Denis | |
| France | CHU SAINT-ETIENNE - Hopital Nord | Saint-etienne | |
| France | Centre Hospitalier de Salon de Provence | Salon de Provence | |
| France | Centre Hospitalier Sainte Catherine | Saverne | |
| France | Centre Hospitalier de Toulon, Hopital Sainte Musse | Toulon | |
| France | CHU TOULOUSE- Hopital Rangueil | Toulouse | |
| France | Centre Hospitalier Valence | Valence | |
| France | Centre Hospitalier de Valenciennes | Valenciennes | |
| Greece | Athens Hippocratio Hospital | Athens | |
| Greece | Naval and Veterans Hospital of Athens | Athens | |
| Greece | University Critical Care Department Aghioi Anargyroi Hospital | Athens | |
| Greece | University Hospital of loannina | Ioánnina | |
| Greece | G. Gennimatas General Hospital | Thessaloníki | |
| United Kingdom | Sandwell and west Birmingham hospital | Birmingham | |
| United Kingdom | University Hospital Birmingham | Birmingham | |
| United Kingdom | Guy'S and St Thomas' | London | |
| United Kingdom | Salford royal | Manchester | |
| United Kingdom | University Hospital of South Manchester | Manchester | |
| United Kingdom | Oxford Radcliffe Hospitals | Oxford | |
| United Kingdom | St Helens and Knowsley Hospitals | Prescot | |
| United Kingdom | Sheffield Teaching Hospitals | Sheffield | |
| United Kingdom | Southampton University Hospitals | Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
Australia, Chile, France, Greece, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Aminoglycoside current practices descriptive data in intensive care units | Seven first days of aminoglycoside therapy | ||
| Secondary | Aminoglycoside dosing regimens | Seven first days of aminoglycoside therapy | ||
| Secondary | Aminoglycoside therapy duration | Seven first days of aminoglycoside therapy | ||
| Secondary | Aminoglycoside therapeutic drug monitoring | Seven first days of aminoglycoside therapy |
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