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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03990467
Other study ID # 69HCL17_0843
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 28, 2021
Est. completion date January 28, 2023

Study information

Verified date September 2022
Source Hospices Civils de Lyon
Contact Arnaud FRIGGERI, MD
Phone 478865647
Email arnaud.friggeri@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 28, 2023
Est. primary completion date January 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma concentration of amikacin during the first 24 hours after administration First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary Change in plasma concentration of piperacillin during the first 24 hours after administration First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary Change in plasma concentration of tazobactam during the first 24 hours after administration First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary Dose administered of amikacin at baseline Hour 0 (Baseline)
Primary Dose administered of piperacillin at baseline Hour 0 (Baseline)
Primary Dose administered of tazobactam at baseline Hour 0 (Baseline)
Primary 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
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary 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
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary 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
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary 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
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary 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
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Primary 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
First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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