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

Study Overview
=================
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.

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

Conditions
-----------------
Underdosing of Aminoglycosides, Critical Illness

Intervention / Treatment
-----------------
* Other: Observational study, no intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| critically ill patients<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aminoglycoside current practices descriptive data in intensive care units |  | Seven first days of aminoglycoside therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aminoglycoside dosing regimens |  | Seven first days of aminoglycoside therapy | 
| Aminoglycoside therapy duration |  | Seven first days of aminoglycoside therapy | 
| Aminoglycoside therapeutic drug monitoring |  | Seven first days of aminoglycoside therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimicrobial, intensive care units