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

Primary Purpose

Septic Shock, Sepsis, Sepsis Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plasma dosage of amikacin, piperacillin and tazobactam
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCLRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients treated by amikacin and piperacillin

Arm Description

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

Outcomes

Primary Outcome Measures

Change in plasma concentration of amikacin during the first 24 hours after administration
Change in plasma concentration of piperacillin during the first 24 hours after administration
Change in plasma concentration of tazobactam during the first 24 hours after administration
Dose administered of amikacin at baseline
Dose administered of piperacillin at baseline
Dose administered of tazobactam at baseline
Change in plasma volume of distribution of amikacin during the first 24 hours after administration
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2019
Last Updated
September 29, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03990467
Brief Title
Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU
Acronym
OPTIMA
Official Title
Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
January 28, 2023 (Anticipated)
Study Completion Date
January 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Sepsis, Sepsis Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients treated by amikacin and piperacillin
Arm Type
Experimental
Arm Description
ICU patient with a sepsis treated by amikacin and piperacillin/tazobactam
Intervention Type
Biological
Intervention Name(s)
Plasma dosage of amikacin, piperacillin and tazobactam
Intervention Description
Pharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
Dose administered of amikacin at baseline
Time Frame
Hour 0 (Baseline)
Title
Dose administered of piperacillin at baseline
Time Frame
Hour 0 (Baseline)
Title
Dose administered of tazobactam at baseline
Time Frame
Hour 0 (Baseline)
Title
Change in plasma volume of distribution of amikacin during the first 24 hours after administration
Description
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
Time Frame
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Title
Change in plasma volume of distribution of piperacillin during the first 24 hours after administration
Description
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
Time Frame
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Title
Change in plasma volume of distribution of tazobactam during the first 24 hours after administration
Description
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
Time Frame
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Title
Change in plasma clearance of amikacin during the first 24 hours after administration
Description
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
Time Frame
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Title
Change in plasma clearance of piperacillin during the first 24 hours after administration
Description
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
Time Frame
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Title
Change in plasma clearance of tazobactam during the first 24 hours after administration
Description
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
Time Frame
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud FRIGGERI, MD
Phone
478865647
Ext
+33
Email
arnaud.friggeri@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alain LEPAPE, MD
Phone
478861989
Ext
+33
Email
alain.lepape@chu-lyon.fr
Facility Information:
Facility Name
Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud FRIGGERI, MD
Phone
478865647
Ext
+33
Email
arnaud.friggeri@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Arnaud FRIGGERI, MD
First Name & Middle Initial & Last Name & Degree
Alain LEPAPE, MD
First Name & Middle Initial & Last Name & Degree
Bernard ALLAOUCHICHE, MD, Prof.
First Name & Middle Initial & Last Name & Degree
Julien BOHE, MD, Prof.
First Name & Middle Initial & Last Name & Degree
Manon MARIE, MD
First Name & Middle Initial & Last Name & Degree
Florent WALLET, MD
First Name & Middle Initial & Last Name & Degree
Olivia VASSAL, MD

12. IPD Sharing Statement

Learn more about this trial

Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

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