Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

Not Applicable

Recruiting

• Conditions: Sepsis Syndrome; Septic Shock; Sepsis
• Interventions: Biological: Plasma dosage of amikacin, piperacillin and tazobactam

• Registration Number: NCT03990467
• Lead Sponsor: Hospices Civils de Lyon

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 available

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2021-01-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30
• Primary Completion: 2023-01-28
• Study Completion: 2023-01-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated by amikacin and piperacillin	Plasma dosage of amikacin, piperacillin and tazobactam	ICU patient with a sepsis treated by amikacin and piperacillin/tazobactam

Primary Outcome Measures

Name	Time	Method
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)
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)
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)
Dose administered of amikacin at baseline	Hour 0 (Baseline)
Dose administered of piperacillin at baseline	Hour 0 (Baseline)
Dose administered of tazobactam at baseline	Hour 0 (Baseline)
Change in plasma volume of distribution 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)	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	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	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	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	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	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

Trial Locations

Locations (1)

Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL; 🇫🇷 Pierre-Bénite, France