Clinical trial NCT03990467: Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU
Official title: Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Sepsis
Sepsis Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in plasma concentration of amikacin during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma concentration of piperacillin during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma concentration of tazobactam during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Dose administered of amikacin at baseline
timeFrame: Hour 0 (Baseline)
measure: Dose administered of piperacillin at baseline
timeFrame: Hour 0 (Baseline)
measure: Dose administered of tazobactam at baseline
timeFrame: Hour 0 (Baseline)
measure: Change in plasma volume of distribution of amikacin during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma volume of distribution of piperacillin during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma volume of distribution of tazobactam during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma clearance of amikacin during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma clearance of piperacillin during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
measure: Change in plasma clearance of tazobactam during the first 24 hours after administration
timeFrame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL
Study officials:
References: