AbioKin - Antibiotic Kinetics
Antibiotic Pharmacokinetics in Critically Ill Patients
1 other identifier
observational
1,500
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedJanuary 19, 2021
July 1, 2016
4.5 years
November 18, 2015
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
linezolid
patients treated with linezolid
meropenem
patients treated with meropenem
piperacillin/tazobactam
patients treated with piperacillin/tazobactam
vancomycin
patients treated with vancomycin
Interventions
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.
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.
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.
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.
Eligibility Criteria
Patients admitted to Intensive Care Unit (ICU)
You may qualify if:
- 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
You may not qualify if:
- patients undergoing antibiotic prophylaxis
- lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
Cesena, Emilia-Romagna, 47023, Italy
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
Florence, FI, 50143, Italy
Ospedale San Giovanni di Dio
Orbetello, Grosseto, 58016, Italy
Presidio Ospedaliero "San Leopoldo Mandic"
Merate, Lecco, 23807, Italy
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
Lecco, Lombardy, 23900, Italy
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Turin, Piedmont, 10148, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100, Italy
Ospedale del Mugello
Borgo San Lorenzo, Tuscany, 50032, Italy
Ospedale Santa Maria Nuova, Anestesia e Rianimazione
Florence, Tuscany, 50122, Italy
Ospedale Maggiore, C.A. Pizzardi
Bologna, 40133, Italy
Ospedale Misericordia
Grosseto, 58016, Italy
Biospecimen
Blood samples to measure antibiotic plasma concentration
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano Finazzi, PhD
Mario Negri Institute for Pharmacological Research
- PRINCIPAL INVESTIGATOR
Elena Garbero, M.Sci
Mario Negri Institute for Pharmacological Research
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 20, 2015
Study Start
January 1, 2016
Primary Completion
June 26, 2020
Study Completion
June 26, 2020
Last Updated
January 19, 2021
Record last verified: 2016-07