Septic ShockOPTIMANCT03990467
Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU
A study testing Plasma dosage of amikacin, piperacillin and tazobactam in people with Septic Shock and Sepsis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis, Sepsis Syndrome
- What is being tested?
- Plasma dosage of amikacin, piperacillin and tazobactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2021to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL
Pierre-Bénite, 69495
Arnaud FRIGGERI, MD, 478865647 ext. +33, arnaud.friggeri@chu-lyon.fr
Arnaud FRIGGERI, MD
About this study
Official title: Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin
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
- Being tested
- Plasma dosage of amikacin, piperacillin and tazobactam
- Medical subject headings
- Shock, Septic, Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma dosage of amikacin, piperacillin and tazobactamBiological
Pharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by amikacin and piperacillin | Experimental | ICU patient with a sepsis treated by amikacin and piperacillin/tazobactam Receives: Biological: Plasma dosage of amikacin, piperacillin and tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentration of amikacin during the first 24 hours after administration
Measured: 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
Measured: 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
Measured: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Dose administered of amikacin at baseline
Measured: Hour 0 (Baseline)
Dose administered of piperacillin at baseline
Measured: Hour 0 (Baseline)
Dose administered of tazobactam at baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start28 Jan 2021
- Primary completion28 Jan 2023 (estimated)
- Study completion28 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990467
- Sponsor's protocol ID
- 69HCL17_0843
- Acronym
- OPTIMA
- Status last verified
- Sep 2022
- First submitted
- 4 Jun 2019
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin
- ClinicalTrials.gov ID
- NCT03990467
- Acronym / sponsor ID
- OPTIMA / 69HCL17_0843
- Conditions
- Septic Shock, Sepsis, Sepsis Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 28 Jan 2023 (estimated)
- Study completion
- 28 Jan 2023 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by amikacin and piperacillin | Experimental | Biological: Plasma dosage of amikacin, piperacillin and tazobactamICU patient with a sepsis treated by amikacin and piperacillin/tazobactam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma dosage of amikacin, piperacillin and tazobactamPharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam | Biological | Patients treated by amikacin and piperacillin |
Primary outcome
Change in plasma concentration of amikacin during the first 24 hours after administration
Time frame: 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
Time frame: 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
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
Dose administered of amikacin at baseline
Time frame: Hour 0 (Baseline)
Dose administered of piperacillin at baseline
Time frame: Hour 0 (Baseline)
Dose administered of tazobactam at baseline
Time frame: Hour 0 (Baseline)
Change in plasma volume of distribution of amikacin during the first 24 hours after administration
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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
Change in plasma volume of distribution of piperacillin during the first 24 hours after administration
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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
Change in plasma volume of distribution of tazobactam during the first 24 hours after administration
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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
Change in plasma clearance of amikacin during the first 24 hours after administration
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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
Change in plasma clearance of piperacillin during the first 24 hours after administration
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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
Change in plasma clearance of tazobactam during the first 24 hours after administration
Time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma dosage of amikacin, piperacillin and tazobactam in people with Septic Shock and Sepsis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud FRIGGERI, MD (478865647 ext. +33, arnaud.friggeri@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma concentration of amikacin during the first 24 hours after administration (time frame: First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.