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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Sepsis Syndrome; Septic Shock; Sepsis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03990467

69HCL17_0843

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients treated by amikacin and piperacillin

Experimental group

Description:

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

Treatment:

Biological: Plasma dosage of amikacin, piperacillin and tazobactam