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AbioKin - Antibiotic Kinetics

NCT02609646 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2021-01-19

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project.

For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.

Conditions

Interventions

DRUG

Linezolid

Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.

DRUG

Meropenem

Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.

DRUG

Piperacillin-tazobactam combination product

Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.

DRUG

Vancomycin

Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.

Sponsors & Collaborators

  • Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

    lead OTHER

Principal Investigators

  • Stefano Finazzi, PhD · Mario Negri Institute for Pharmacological Research

  • Elena Garbero, M.Sci · Mario Negri Institute for Pharmacological Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-06-26
Completion
2020-06-26

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609646 on ClinicalTrials.gov