NCT03990467

Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Sepsis
• Sepsis Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-28
• Primary completion: 2023-01-28
• Completion: 2023-01-28
• First posted: 2019-06-19
• Last updated: 2022-09-30

Locations

1 site across 1 country: France