AbioKin - Antibiotic Kinetics

Sponsor

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Other)

Overall Status

Completed

CT.gov ID

NCT02609646

Collaborator

(none)

1,500

Enrollment

Locations

53.8

Actual Duration (Months)

136.4

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Infection	Drug: Linezolid Drug: Meropenem Drug: Piperacillin-tazobactam combination product Drug: Vancomycin

Study Design

Study Type:

Observational

Actual Enrollment :

1500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Antibiotic Pharmacokinetics in Critically Ill Patients

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 26, 2020

Actual Study Completion Date :

Jun 26, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva	Cesena	Emilia Romagna	Italy	47023
2	Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione	Firenze	FI	Italy	50143
3	Ospedale San Giovanni di Dio	Orbetello	Grosseto	Italy	58016
4	Presidio Ospedaliero "San Leopoldo Mandic"	Merate	Lecco	Italy	23807
5	Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1	Lecco	Lombardia	Italy	23900
6	Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA	Torino	Piemonte	Italy	10148
7	Fondazione IRCCS Policlinico San Matteo	Pavia	PV	Italy	27100
8	Ospedale del Mugello	Borgo San Lorenzo	Toscana	Italy	50032
9	Ospedale Santa Maria Nuova, Anestesia e Rianimazione	Firenze	Toscana	Italy	50122
10	Ospedale Maggiore, C.A. Pizzardi	Bologna		Italy	40133
11	Ospedale Misericordia	Grosseto		Italy	58016

Sponsors and Collaborators

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