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

Completed

• Conditions: Underdosing of Aminoglycosides; Critical Illness

• Registration Number: NCT02850029
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study Start: 2016-05-21
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 964

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aminoglycoside current practices descriptive data in intensive care units	Seven first days of aminoglycoside therapy

Secondary Outcome Measures

Name	Time	Method
Aminoglycoside therapy duration	Seven first days of aminoglycoside therapy
Aminoglycoside therapeutic drug monitoring	Seven first days of aminoglycoside therapy
Aminoglycoside dosing regimens	Seven first days of aminoglycoside therapy

Trial Locations

Locations (83)

Royal Brisbane Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia

Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Australia

Frankston Hospital Victoria; 🇦🇺 Frankston, Australia

Sunshine Coast hospital; 🇦🇺 Sunshine Coast, Australia

Toowoomba Hospital; 🇦🇺 Toowoomba, Australia

Hospital Base de Valvidia; 🇨🇱 Valdivia, Region DE LOS RIOS, Chile

Hospital Barros Luco Trudeau; 🇨🇱 Santiago, Chile

Hospital CU Chile; 🇨🇱 Santiago, Chile

Salvador Santiago Hospital; 🇨🇱 Santiago, Chile

APHM La timone; 🇫🇷 Marseille, Paca, France

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