AbioKin - Antibiotic Kinetics

NCT ID: NCT02609646

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-06-26

Brief 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

Critical Illness; Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

linezolid

patients treated with linezolid

Linezolid

Intervention Type: 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

patients treated with meropenem

Meropenem

Intervention Type: 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.

piperacillin/tazobactam

patients treated with piperacillin/tazobactam

Piperacillin-tazobactam combination product

Intervention Type: 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.

vancomycin

patients treated with vancomycin

Vancomycin

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Finazzi, PhD

Role: PRINCIPAL_INVESTIGATOR

Mario Negri Institute for Pharmacological Research

Elena Garbero, M.Sci

Role: PRINCIPAL_INVESTIGATOR

Mario Negri Institute for Pharmacological Research

Locations

Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva

Cesena, Emilia-Romagna, Italy

Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione

Florence, FI, Italy

Ospedale San Giovanni di Dio

Orbetello, Grosseto, Italy

Presidio Ospedaliero "San Leopoldo Mandic"

Merate, Lecco, Italy

Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1

Lecco, Lombardy, Italy

Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA

Turin, Piedmont, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Ospedale del Mugello

Borgo San Lorenzo, Tuscany, Italy

Ospedale Santa Maria Nuova, Anestesia e Rianimazione

Florence, Tuscany, Italy

Ospedale Maggiore, C.A. Pizzardi

Bologna, , Italy

Ospedale Misericordia

Grosseto, , Italy

Countries

Italy

Other Identifiers

AbioKin

Identifier Type: -

Identifier Source: org_study_id