Resuscitation Patients With SepsisOPT-TAZNCT03748095
Population Pharmacokinetic Modeling to Optimize the Dosage of the Piperacillin / Tazobactam Combination in Patients With Sepsis in Intensive Care
An observational study of Resuscitation Patients With Sepsis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. We propose to model a Bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resuscitation Patients With Sepsis
- What is being tested?
- Intensive Pharmacokinetic Sampling Cohort and Sparse Pharmacokinetic Sampling Cohort
- Type of treatment
- Injection or infusion
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2019to 12 Sep 2023
- Phase
- Observational
- 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
Study population: Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3"
Who may be able to join
- Major patient (age ≥18 years) male or female.
- Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3".
- Patient with an arterial catheter that can be used for blood sampling by the time the first dose of piperacillin / tazobactam is administered.
- Patient for whom treatment with piperacillin / tazobactam, alone or in combination with another antibiotic, is prescribed according to the following modalities (drug SPC): scheduled antibiotic treatment for at least 48 hours in IV infusion of 4 g of piperacillin and 0.5 g tazobactam over 3 hours, every 6 hours or every 8 hours.
- Patient affiliated to a social security scheme.
- Patient informed and given his non-opposition. If the patient is unable to do so (emergency situations) the non-opposition will be obtained from the patient's representative.
Who cannot join
- Treatment with piperacillin and / or tazobactam within 7 days prior to evaluation.
- Patient with a history of allergy to penicillins or β-lactams.
- Kidney function of Kdigo score = 3 (3 times baseline plasma creatinine or plasma creatinine ≥ 354μmol / L or extra-renal clearance, or diuresis <0.3ml / kg / h for ≥ 24h or anuria for ≥ 12h) to not include patients at very high risk of extra-renal clearance within 48 hours.
- Hypersensitivity to the active substances, to any other antibacterial agent of the penicillin class or to any of the excipients.
- History of severe allergic reaction to any other β-lactam.
- Patient being treated with extrarenal treatment.
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- Patient being treated with extracorporeal circulation (ECMO).
- Hepatic insufficiency patient with Child C. cirrhosis.
- Patient who refused to participate or refused participation by the representative.
- Person deprived of liberty by an administrative or judicial decision.
- Person under tutorship or curatorship.
- Pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
About this study
Population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. We propose to model a Bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam combination in a target population of sepsis, to allow for early assessment of serum Piperacillin / Tazobactam concentration profiles. optimization of dosing regimens. Indeed, pharmacokinetic tools of this type are already regularly successfully applied for other classes of antibiotics or immunosuppressants whose therapeutic index is narrow. They reduce the toxic risk and optimize the effectiveness of these treatments.
- Conditions
- Resuscitation Patients With Sepsis
- Being tested
- Intensive Pharmacokinetic Sampling Cohort, Sparse Pharmacokinetic Sampling Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Pharmacokinetic Sampling CohortDrug
For the first 60 patients, blood samples were collected in 2-mL dry tubes at T0, 90 min, 3 h, 4 h, 5 h, 6 h, 12 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 6 hours; or at T0, 90 min, 3 h, 4 h, 6 h, 8 h, 16 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 8 hours, for piperacillin/tazobactam concentration measurement.
Sparse Pharmacokinetic Sampling CohortDrug
For the last 30 patients, blood samples of 2 mL collected in dry tubes at T0, T6h (if administered every 6 hours) or T8h (if administered every 8 hours), then T24h, T48h, and T120h after initiation of treatment via 3-hour infusions.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Pharmacokinetic Sampling Cohort | Not described Receives: Drug: Intensive Pharmacokinetic Sampling Cohort | |
| Sparse Pharmacokinetic Sampling Cohort | Not described Receives: Drug: Sparse Pharmacokinetic Sampling Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective is to develop a Bayesian estimator of the area under the blood concentration curves of the piperacillin / tazobactam combination in resuscitation patients with sepsis.
The primary endpoint of this study is the ability of the pharmacokinetic model developed to predict the AUC of the piperacillin / tazobactam combination at 24 hours after initiation of antibiotic therapy.
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start12 Mar 2019
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resuscitation Patients With SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748095
- Sponsor's protocol ID
- 2017/0384/HP
- Other IDs
- 2017/384/HP
- Acronym
- OPT-TAZ
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2018
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic Modeling to Optimize the Dosage of the Piperacillin / Tazobactam Combination in Patients With Sepsis in Intensive Care
- ClinicalTrials.gov ID
- NCT03748095
- Acronym / sponsor ID
- OPT-TAZ / 2017/0384/HP
- Conditions
- Resuscitation Patients With Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 20 Nov 2018 (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.
Population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. We propose to model a Bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam combination in a target population of sepsis, to allow for early assessment of serum Piperacillin / Tazobactam concentration profiles. optimization of dosing regimens. Indeed, pharmacokinetic tools of this type are already regularly successfully applied for other classes of antibiotics or immunosuppressants whose therapeutic index is narrow. They reduce the toxic risk and optimize the effectiveness of these treatments.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Pharmacokinetic Sampling Cohort | – | Drug: Intensive Pharmacokinetic Sampling Cohort |
| Sparse Pharmacokinetic Sampling Cohort | – | Drug: Sparse Pharmacokinetic Sampling Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3"
Key inclusion criteria (6 listed)
- Major patient (age ≥18 years) male or female.
- Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3".
- Patient with an arterial catheter that can be used for blood sampling by the time the first dose of piperacillin / tazobactam is administered.
- Patient for whom treatment with piperacillin / tazobactam, alone or in combination with another antibiotic, is prescribed according to the following modalities (drug SPC): scheduled antibiotic treatment for at least 48 hours in IV infusion of 4 g of piperacillin and 0.5 g tazobactam over 3 hours, every 6 hours or every 8 hours.
- Patient affiliated to a social security scheme.
Key exclusion criteria (12 listed)
- Treatment with piperacillin and / or tazobactam within 7 days prior to evaluation.
- Patient with a history of allergy to penicillins or β-lactams.
- Kidney function of Kdigo score = 3 (3 times baseline plasma creatinine or plasma creatinine ≥ 354μmol / L or extra-renal clearance, or diuresis <0.3ml / kg / h for ≥ 24h or anuria for ≥ 12h) to not include patients at very high risk of extra-renal clearance within 48 hours.
- Hypersensitivity to the active substances, to any other antibacterial agent of the penicillin class or to any of the excipients.
- History of severe allergic reaction to any other β-lactam.
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 |
|---|---|---|
| Intensive Pharmacokinetic Sampling CohortFor the first 60 patients, blood samples were collected in 2-mL dry tubes at T0, 90 min, 3 h, 4 h, 5 h, 6 h, 12 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 6 hours; or at T0, 90 min, 3 h, 4 h, 6 h, 8 h, 16 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 8 hours, for piperacillin/tazobactam concentration measurement. | Drug | Intensive Pharmacokinetic Sampling Cohort |
| Sparse Pharmacokinetic Sampling CohortFor the last 30 patients, blood samples of 2 mL collected in dry tubes at T0, T6h (if administered every 6 hours) or T8h (if administered every 8 hours), then T24h, T48h, and T120h after initiation of treatment via 3-hour infusions. | Drug | Sparse Pharmacokinetic Sampling Cohort |
Primary outcome
The objective is to develop a Bayesian estimator of the area under the blood concentration curves of the piperacillin / tazobactam combination in resuscitation patients with sepsis.
Time frame: 24hours
The primary endpoint of this study is the ability of the pharmacokinetic model developed to predict the AUC of the piperacillin / tazobactam combination at 24 hours after initiation of antibiotic therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resuscitation Patients With Sepsis, run by University Hospital, Rouen 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective is to develop a Bayesian estimator of the area under the blood concentration curves of the piperacillin / tazobactam combination in resuscitation patients with sepsis. (time frame: 24hours). 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 29 Jun 2026.