AbioKin - Antibiotic Kinetics

Antibiotic Pharmacokinetics in Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Infection
• Intervention / Treatment: Drug: Linezolid; Drug: Meropenem; Drug: Piperacillin-tazobactam combination product; Drug: Vancomycin

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40133
    • Ospedale Maggiore, C.A. Pizzardi
  • Grosseto, Italy, 58016
    • Ospedale Misericordia
  • Emilia Romagna
    • Cesena, Emilia Romagna, Italy, 47023
      • Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
  • FI
    • Firenze, FI, Italy, 50143
      • Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
  • Grosseto
    • Orbetello, Grosseto, Italy, 58016
      • Ospedale San Giovanni di Dio
  • Lecco
    • Merate, Lecco, Italy, 23807
      • Presidio Ospedaliero "San Leopoldo Mandic"
  • Lombardia
    • Lecco, Lombardia, Italy, 23900
      • Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
  • PV
    • Pavia, PV, Italy, 27100
      • Fondazione Irccs Policlinico San Matteo
  • Piemonte
    • Torino, Piemonte, Italy, 10148
      • Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
  • Toscana
    • Borgo San Lorenzo, Toscana, Italy, 50032
      • Ospedale Del Mugello
    • Firenze, Toscana, Italy, 50122
      • Ospedale Santa Maria Nuova, Anestesia e Rianimazione

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Intensive Care Unit (ICU)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
linezolid; patients treated with linezolid	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.
meropenem; patients treated with meropenem	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.
piperacillin/tazobactam; patients treated with piperacillin/tazobactam	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.
vancomycin; patients treated with vancomycin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Drug plasma concentration (time-dependent antibiotics)	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)	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

Collaborators and Investigators

• Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Investigators: Principal Investigator: Stefano Finazzi, PhD, Mario Negri Institute for Pharmacological Research; Principal Investigator: Elena Garbero, M.Sci, Mario Negri Institute for Pharmacological Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): June 26, 2020
• Study Completion (ACTUAL): June 26, 2020

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (ESTIMATE): November 20, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Anti-Infective Agents; Pharmacokinetics; Critically ill patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; beta-Lactamase Inhibitors; Vancomycin; Linezolid; Meropenem; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: AbioKin