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AbioKin - Antibiotic Kinetics

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ClinicalTrials.gov Identifier: NCT02609646
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Critical Illness Infection Drug: Linezolid Drug: Meropenem Drug: Piperacillin-tazobactam combination product Drug: Vancomycin

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Antibiotic Pharmacokinetics in Critically Ill Patients
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort 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.




Primary Outcome Measures :
  1. Drug plasma concentration (time-dependent antibiotics) [ Time Frame: 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 ]
  2. Drug plasma concentration (concentration-dependent antibiotics) [ Time Frame: 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 ]

Biospecimen Retention:   Samples Without DNA
Blood samples to measure antibiotic plasma concentration


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to Intensive Care Unit (ICU)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609646


Contacts
Contact: Stefano Finazzi, PhD +390354545352 stefano.finazzi@marionegri.it
Contact: Elena Garbero, M.Sci +390354545412 elena.garbero@marionegri.it

Locations
Italy
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva Recruiting
Cesena, Emilia Romagna, Italy, 47023
Contact: Marco Benni, MD         
Principal Investigator: Marco Benni, MD         
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione Not yet recruiting
Firenze, FI, Italy, 50143
Principal Investigator: Valerio Mangani, MD         
Presidio Ospedaliero "San Leopoldo Mandic" Recruiting
Merate, Lecco, Italy, 23807
Contact: Davide Guzzon, MD         
Principal Investigator: Davide Guzzon, MD         
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1 Recruiting
Lecco, Lombardia, Italy, 23900
Contact: Giuseppe Nattino, MD         
Principal Investigator: Giuseppe Nattino, MD         
Sub-Investigator: Rita Ciceri, MD         
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA Not yet recruiting
Torino, Piemonte, Italy, 10148
Contact: Daniela Silengo, MD         
Principal Investigator: Daniela Silengo, MD         
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, PV, Italy, 27100
Contact: Alessandro Amatu, MD         
Principal Investigator: Alessandro Amatu, MD         
Ospedale Giovanni Paolo II Not yet recruiting
Olbia, Sardegna, Italy, 07026
Contact: Maria Giovanna Dessena, MD    0789552984      
Principal Investigator: Maria Giovanna Dessena, MD         
Ospedale del Mugello Not yet recruiting
Borgo San Lorenzo, Toscana, Italy, 50032
Contact: Rossella Carlà, MD         
Principal Investigator: Rossella Carlà, MD         
Ospedale Santa Maria Nuova, Anestesia e Rianimazione Not yet recruiting
Firenze, Toscana, Italy, 50122
Contact: Massimo Barattini, MD         
Principal Investigator: Massimo Barattini, MD         
Ospedale Alta Val d'Elsa, Terapia Intensiva Not yet recruiting
Poggibonsi, Toscana, Italy, 53036
Contact: Andrea Veneziani, MD         
Principal Investigator: Andrea Veneziani, MD         
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

Responsible Party: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
ClinicalTrials.gov Identifier: NCT02609646     History of Changes
Other Study ID Numbers: AbioKin
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva:
Anti-Infective Agents
Pharmacokinetics
Critically ill patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Vancomycin
Linezolid
Meropenem
Tazobactam
Piperacillin
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors