Critical IllnessNCT02609646
AbioKin - Antibiotic Kinetics
An observational study of Critical Illness and Infection, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 11 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Infection
- What is being tested?
- Linezolid, Meropenem and Piperacillin-tazobactam combination product
- How many people
- 1,500 participants
- Where
- 11 sitesItaly
- Study dates
- Jan 2016to 26 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Intensive Care Unit (ICU)
Who may be able to join
- 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
Who cannot join
- patients undergoing antibiotic prophylaxis
- lack of informed consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Ospedale Maggiore, C.A. Pizzardi
Bologna, 40133
Ospedale del Mugello
Borgo San Lorenzo, Tuscany, 50032
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
Cesena, Emilia-Romagna, 47023
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
Florence, FI, 50143
Ospedale Santa Maria Nuova, Anestesia e Rianimazione
Florence, Tuscany, 50122
Ospedale Misericordia
Grosseto, 58016
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
Lecco, Lombardy, 23900
Presidio Ospedaliero "San Leopoldo Mandic"
Merate, Lecco, 23807
Ospedale San Giovanni di Dio
Orbetello, Grosseto, 58016
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Turin, Piedmont, 10148
About this study
Official title: Antibiotic Pharmacokinetics in Critically Ill Patients
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.
- Conditions
- Critical Illness, Infection
- Being tested
- Linezolid, Meropenem, Piperacillin-tazobactam combination product, Vancomycin
- Keywords
- Anti-Infective Agents, Pharmacokinetics, Critically ill patients
- Medical subject headings
- Critical Illness, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
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.
MeropenemDrug
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 productDrug
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.
VancomycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| linezolid | patients treated with linezolid Receives: Drug: Linezolid | |
| meropenem | patients treated with meropenem Receives: Drug: Meropenem | |
| piperacillin/tazobactam | patients treated with piperacillin/tazobactam Receives: Drug: Piperacillin-tazobactam combination product | |
| vancomycin | patients treated with vancomycin Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug plasma concentration (time-dependent antibiotics)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Finazzi, PhD, Principal investigator, Mario Negri Institute for Pharmacological ResearchElena Garbero, M.Sci, Principal investigator, Mario Negri Institute for Pharmacological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609646
- Sponsor's protocol ID
- AbioKin
- Status last verified
- Jul 2016
- First submitted
- 18 Nov 2015
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Pharmacokinetics in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02609646
- Acronym / sponsor ID
- AbioKin
- Conditions
- Critical Illness, Infection
- Keywords
- Anti-Infective Agents, Pharmacokinetics, Critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia IntensivaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| linezolid | – | Drug: Linezolidpatients treated with linezolid |
| meropenem | – | Drug: Meropenempatients treated with meropenem |
| piperacillin/tazobactam | – | Drug: Piperacillin-tazobactam combination productpatients treated with piperacillin/tazobactam |
| vancomycin | – | Drug: Vancomycinpatients treated with vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Intensive Care Unit (ICU)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients undergoing antibiotic prophylaxis
- lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinezolidDrug 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 | linezolid |
| MeropenemDrug 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 | meropenem |
| Piperacillin-tazobactam combination productDrug 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 | piperacillin/tazobactam |
| VancomycinDrug 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 | vancomycin |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Finazzi, PhD principal investigator
Mario Negri Institute for Pharmacological Research
Elena Garbero, M.Sci principal investigator
Mario Negri Institute for Pharmacological Research
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Infection, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021; AzTrials last refreshed its copy on 3 Nov 2026.