Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

NCT03990467 | Unknown

• 1 other identifier: 69HCL17_0843
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Sepsis; Sepsis Syndrome

Outcome Measures

Primary Outcomes (12)

• 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)

• 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)

• 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)

• Dose administered of amikacin at baseline

  Hour 0 (Baseline)

• Dose administered of piperacillin at baseline

  Hour 0 (Baseline)

• Dose administered of tazobactam at baseline

  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

  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

  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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Patients treated by amikacin and piperacillin

EXPERIMENTAL

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

Biological: Plasma dosage of amikacin, piperacillin and tazobactam

Interventions

Plasma dosage of amikacin, piperacillin and tazobactam BIOLOGICAL

Pharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam

Patients treated by amikacin and piperacillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Sepsis; Systemic Inflammatory Response Syndrome

Interventions

Piperacillin; Tazobactam

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones

Central Study Contacts

Arnaud FRIGGERI, MD

CONTACT

478865647; arnaud.friggeri@chu-lyon.fr

Alain LEPAPE, MD

CONTACT

478861989; alain.lepape@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 19, 2019
• Study Start: January 28, 2021
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

FR (1)