AbioKin - Antibiotic Kinetics

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.

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Key information

Conditions

Critical Illness Disease Attributes Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva, Cesena, Emilia-Romagna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin.
patients whose antibiotic therapy started during the stay in ICU or less than 24h before admission to ICU.
patients with anticipated length of stay in ICU of at least 24h.
patients with already-placed catheter

Exclusion criteria

patients undergoing antibiotic prophylaxis
lack of informed consent

Treatment and study plan

Linezolid

Drug

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.

Meropenem

Drug

Piperacillin-tazobactam combination product

Drug

Vancomycin

Drug

Primary outcomes

Drug plasma concentration (time-dependent antibiotics)

Time frame: 30 min after first dose; 1 day after first dose; 2 day after first dose; 2 measures between the 3rd and the 8th day of treatment
Drug plasma concentration (concentration-dependent antibiotics)

Time frame: 30 min after first dose; immediately before second dose; peak and trough of the same dose in the 2nd day of therapy; peak and trough of the same dose between the 3rd and the 5th day of therapy

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Other

Registry information

Official study title

Antibiotic Pharmacokinetics in Critically Ill Patients

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Nov 20, 2015
Registry last updated: Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed