Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

Sepsis Clinical Trial

— OPTIMA  

Official title:

Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990467
• Other study ID #: 69HCL17_0843
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sepsis
• Sepsis Syndrome
• Septic Shock
• Systemic Inflammatory Response Syndrome
• Toxemia

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)