AbioKin - Antibiotic Kinetics

Completed

• Conditions: Infection; Critical Illness
• Interventions: Drug: Piperacillin-tazobactam combination product; Drug: Linezolid; Drug: Meropenem; Drug: Vancomycin

• Registration Number: NCT02609646
• Lead Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2016-01
• Status Verified: 2016-07
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
piperacillin/tazobactam	Piperacillin-tazobactam combination product	patients treated with piperacillin/tazobactam
linezolid	Linezolid	patients treated with linezolid
meropenem	Meropenem	patients treated with meropenem
vancomycin	Vancomycin	patients treated with vancomycin

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione; 🇮🇹 Firenze, FI, Italy

Ospedale San Giovanni di Dio; 🇮🇹 Orbetello, Grosseto, Italy

Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1; 🇮🇹 Lecco, Lombardia, Italy

Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva; 🇮🇹 Cesena, Emilia Romagna, Italy

Presidio Ospedaliero "San Leopoldo Mandic"; 🇮🇹 Merate, Lecco, Italy

Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA; 🇮🇹 Torino, Piemonte, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, PV, Italy

Ospedale Maggiore, C.A. Pizzardi; 🇮🇹 Bologna, Italy

Ospedale Misericordia; 🇮🇹 Grosseto, Italy

Ospedale del Mugello; 🇮🇹 Borgo San Lorenzo, Toscana, Italy

Ospedale Santa Maria Nuova, Anestesia e Rianimazione; 🇮🇹 Firenze, Toscana, Italy