Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

Hospices Civils de Lyon60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock Sepsis Sepsis Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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)

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)

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

Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)

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)

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)

Central Contacts

Arnaud FRIGGERI, MD

CONTACT

478865647 arnaud.friggeri@chu-lyon.fr

Alain LEPAPE, MD

CONTACT

478861989 alain.lepape@chu-lyon.fr

Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts