Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU (OPTIMA)

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ClinicalTrials.gov Identifier: NCT03990467

Recruitment Status : Recruiting

First Posted : June 19, 2019

Last Update Posted : September 30, 2022

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Hospices Civils de Lyon

Tracking Information

First Submitted Date ^ICMJE

June 4, 2019

First Posted Date ^ICMJE

June 19, 2019

Last Update Posted Date

September 30, 2022

Actual Study Start Date ^ICMJE

January 28, 2021

Estimated Primary Completion Date

January 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in plasma concentration of amikacin during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
Change in plasma concentration of piperacillin during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
Change in plasma concentration of tazobactam during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
Dose administered of amikacin at baseline [ Time Frame: Hour 0 (Baseline) ]
Dose administered of piperacillin at baseline [ Time Frame: Hour 0 (Baseline) ]
Dose administered of tazobactam at baseline [ Time Frame: Hour 0 (Baseline) ]
Change in plasma volume of distribution of amikacin during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
Change in plasma volume of distribution of piperacillin during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
Change in plasma volume of distribution of tazobactam during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
Change in plasma clearance of amikacin during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered
Change in plasma clearance of piperacillin during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered
Change in plasma clearance of tazobactam during the first 24 hours after administration [ Time Frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) ]
In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

Official Title ^ICMJE

Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin

Brief Summary

The pharmacokinetics of antimicrobials is profoundly modified in Intensive care unit (ICU) patients. To adapt the treatment, it is recommended to measure blood levels of antibiotics. Some antibiotics, such as amikacin, are easy to monitor, while for other molecules, such as piperacillin/tazobactam, the drug monitoring is more difficult to obtain. These two molecules have similar physicochemical characteristics (hydrophilicity) and therefore have closed pharmacokinetic properties. OPTIMA is a study aiming at criteria will be used to judge whether the pharmacokinetic (PK) parameters of amikacin are predictive of those of piperacillin and tazobactam.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Septic Shock
Sepsis
Sepsis Syndrome

Intervention ^ICMJE

Biological: Plasma dosage of amikacin, piperacillin and tazobactam

Pharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam

Study Arms ^ICMJE

Experimental: Patients treated by amikacin and piperacillin

ICU patient with a sepsis treated by amikacin and piperacillin/tazobactam

Intervention: Biological: Plasma dosage of amikacin, piperacillin and tazobactam

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

January 28, 2023

Estimated Primary Completion Date

January 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient ≥ 18 years old
Patient hospitalized in the critical care department of the Lyon-Sud hospital centre
Patient with a sepsis or a severe sepsis table defined by the latest international recommendations
Patient to be treated by the amikacin + piperacillin/tazobactam association
Patient affiliated to a social security system, having agreed to participate in the study

Exclusion Criteria:

Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam
Patient known to have previously received piperacillin/tazobactam or amikacin combination before inclusion
Patient treated at the time of inclusion with dialysis techniques

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Arnaud FRIGGERI, MD	478865647 ext +33	arnaud.friggeri@chu-lyon.fr
Contact: Alain LEPAPE, MD	478861989 ext +33	alain.lepape@chu-lyon.fr

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03990467

Other Study ID Numbers ^ICMJE

69HCL17_0843

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Hospices Civils de Lyon

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Hospices Civils de Lyon

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Hospices Civils de Lyon

Verification Date

September 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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