Clinical trial NCT02609646: AbioKin - Antibiotic Kinetics
Official title: Antibiotic Pharmacokinetics in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Infection
Keywords: Anti-Infective Agents
Pharmacokinetics
Critically ill patients
Lead sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Intensive Care Unit (ICU)

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.


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

Primary outcomes:
measure: Drug plasma concentration (time-dependent antibiotics)
timeFrame: 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
measure: Drug plasma concentration (concentration-dependent antibiotics)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cesena
country: Italy
facility: Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
state: Emilia Romagna
city: Firenze
country: Italy
facility: Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
state: FI
city: Orbetello
country: Italy
facility: Ospedale San Giovanni di Dio
state: Grosseto
city: Merate
country: Italy
facility: Presidio Ospedaliero "San Leopoldo Mandic"
state: Lecco
city: Lecco
country: Italy
facility: Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
state: Lombardia
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
state: Piemonte
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: PV
city: Borgo San Lorenzo
country: Italy
facility: Ospedale del Mugello
state: Toscana
city: Firenze
country: Italy
facility: Ospedale Santa Maria Nuova, Anestesia e Rianimazione
state: Toscana
city: Bologna
country: Italy
facility: Ospedale Maggiore, C.A. Pizzardi
city: Grosseto
country: Italy
facility: Ospedale Misericordia
Study officials:
affiliation: Mario Negri Institute for Pharmacological Research
name: Stefano Finazzi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mario Negri Institute for Pharmacological Research
name: Elena Garbero, M.Sci
role: PRINCIPAL_INVESTIGATOR
References: