AbioKin - Antibiotic Kinetics

Critical Illness Clinical Trial

Official title:

Antibiotic Pharmacokinetics in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609646
• Other study ID #: AbioKin
• Status: Completed
• Start date: January 2016
• Est. completion date: June 26, 2020

Study information

• Verified date: July 2016
• Source: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Infection

Intervention

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
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 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
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.

Locations

Country	Name	City	State
Italy	Ospedale Maggiore, C.A. Pizzardi	Bologna
Italy	Ospedale del Mugello	Borgo San Lorenzo	Toscana
Italy	Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva	Cesena	Emilia Romagna
Italy	Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione	Firenze	FI
Italy	Ospedale Santa Maria Nuova, Anestesia e Rianimazione	Firenze	Toscana
Italy	Ospedale Misericordia	Grosseto
Italy	Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1	Lecco	Lombardia
Italy	Presidio Ospedaliero "San Leopoldo Mandic"	Merate	Lecco
Italy	Ospedale San Giovanni di Dio	Orbetello	Grosseto
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	PV
Italy	Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA	Torino	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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