InfectionsPhase 4NCT06690905
Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity
A Phase 4 study testing Piperacillin-tazobactam administered in a prolonged infusion and Piperacillin-tazobactam administered in a standard infusion in people with Infections and Obesity and Obesity-related Medical Conditions, run by CR-CSSS Champlain-Charles-Le Moyne at 1 site in Canada.
Trial summary
This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Piperacillin-tazobactam administered in a prolonged infusion and Piperacillin-tazobactam administered in a standard infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2025to 27 Nov 2025
- Phase
- Phase 4
- 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
- Adults (18 years and older)
- Patients hospitalized at Hôpital Charles-Le Moyne
- Obesity (as defined by a body mass index of ≥ 30 kg/m^2)
- Piperacillin-tazobactam prescription initiated within last 24 hours
- Planned duration of piperacillin-tazobactam of 24 hours or more
Who cannot join
- Documented allergy to beta-lactams of the penicillin class
- Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)
- Pregnancy
- History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy
- Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity: an Open Randomized Controlled Feasibility Study
This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.
- Being tested
- Piperacillin-tazobactam administered in a prolonged infusion, Piperacillin-tazobactam administered in a standard infusion
- Keywords
- Obesity, Piperacillin-tazobactam, Pharmacodynamics
- Medical subject headings
- Infections, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-tazobactam administered in a prolonged infusionDrug
For patients with the prolonged infusion intervention, the piperacillin-tazobactam dose will be administered via 100 ml 0.9% NaCl mini-bags infused and a volumetric pump over 3 hours for piperacillin-tazobactam dosages every 6 hours or overs 4 hours for piperacillin-tazobactam dosages every 8 hours.
Piperacillin-tazobactam administered in a standard infusionDrug
For patients with the standard infusion intervention, the piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin-tazobactam administered in a prolonged infusion | Experimental | Piperacillin-tazobactam dose will be administered over 3 hours for piperacillin-tazobactam dosages every 6 hours or over 4 hours for piperacillin-tazobactam dosages every 8 hours. Receives: Drug: Piperacillin-tazobactam administered in a prolonged infusion |
| Piperacillin-tazobactam administered in a standard infusion | Active comparator | Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph) Receives: Drug: Piperacillin-tazobactam administered in a standard infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence to the sampling protocol
Rate of patients whose blood collection takes place 24 hours after the start of administration of piperacillin-tazobactam according to the method of administration assigned during randomization
Measured: At 24 hours of treatment of piperacillin-tazobactam after randomization
Recruitment rate
Proportion of patients meeting the eligibility criteria who consent to the study.
Measured: At the randomization
Achievement of a prespecified number of patients recruited per month
Achievement of a number of patients recruited per month of 5 to 8 patients
Measured: At the randomization
Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period
Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period
Measured: From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription
Secondary outcomes (5)
Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention
Proportion of patients reaching the target of the time the free concentration of the drug remains above the MIC during the dosing interval (i.e. fT>MIC) equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention
Measured: At 24 hours of treatment of piperacillin-tazobactam after randomization
Number of days of piperacillin-tazobactam treatment under study
Evaluate the number of days of piperacillin-tazobactam treatment under study
Measured: From enrollment to the last dose of the intervention, assessed up to 42 days
Need of escalation to carbapenems antibiotics
Assess if there has been an escalation to carbapenem antibiotics
Measured: From enrollment to the last dose of the intervention, assessed up to 42 days
Incidence of adverse events attributed to the intervention
Evaluate the incidence of adverse effects attributed to the intervention
Measured: From enrollment to the last dose of the intervention, assessed up to 42 days
Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch
Evaluate the number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch, if necessary
Measured: From enrollment to the last dose of the intervention, assessed up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start26 Feb 2025
- Primary completion1 Sep 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CR-CSSS Champlain-Charles-Le Moyne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benoit Crevier, CR-CSSS Champlain-Charles-Le Moyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690905
- Sponsor's protocol ID
- 2025-956
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2024
- Last updated
- 17 Mar 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity: an Open Randomized Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT06690905
- Acronym / sponsor ID
- 2025-956
- Keywords
- Obesity, Piperacillin-tazobactam, Pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CR-CSSS Champlain-Charles-Le MoyneUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 15 Nov 2024 (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.
This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin-tazobactam administered in a prolonged infusion | Experimental | Drug: Piperacillin-tazobactam administered in a prolonged infusionPiperacillin-tazobactam dose will be administered over 3 hours for piperacillin-tazobactam dosages every 6 hours or over 4 hours for piperacillin-tazobactam dosages every 8 hours. |
| Piperacillin-tazobactam administered in a standard infusion | Active comparator | Drug: Piperacillin-tazobactam administered in a standard infusionPiperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18 years and older)
- Patients hospitalized at Hôpital Charles-Le Moyne
- Obesity (as defined by a body mass index of ≥ 30 kg/m^2)
- Piperacillin-tazobactam prescription initiated within last 24 hours
- Planned duration of piperacillin-tazobactam of 24 hours or more
Key exclusion criteria (5 listed)
- Documented allergy to beta-lactams of the penicillin class
- Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)
- Pregnancy
- History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy
- Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization
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 |
|---|---|---|
| Piperacillin-tazobactam administered in a prolonged infusionFor patients with the prolonged infusion intervention, the piperacillin-tazobactam dose will be administered via 100 ml 0.9% NaCl mini-bags infused and a volumetric pump over 3 hours for piperacillin-tazobactam dosages every 6 hours or overs 4 hours for piperacillin-tazobactam dosages every 8 hours. | Drug | Piperacillin-tazobactam administered in a prolonged infusion |
| Piperacillin-tazobactam administered in a standard infusionFor patients with the standard infusion intervention, the piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph) | Drug | Piperacillin-tazobactam administered in a standard infusion |
Primary outcome
Rate of adherence to the sampling protocol
Time frame: At 24 hours of treatment of piperacillin-tazobactam after randomization
Rate of patients whose blood collection takes place 24 hours after the start of administration of piperacillin-tazobactam according to the method of administration assigned during randomization
Recruitment rate
Time frame: At the randomization
Proportion of patients meeting the eligibility criteria who consent to the study.
Achievement of a prespecified number of patients recruited per month
Time frame: At the randomization
Achievement of a number of patients recruited per month of 5 to 8 patients
Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period
Time frame: From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription
Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period
5 secondary outcomes
Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention
Time frame: At 24 hours of treatment of piperacillin-tazobactam after randomization
Number of days of piperacillin-tazobactam treatment under study
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
Need of escalation to carbapenems antibiotics
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
Incidence of adverse events attributed to the intervention
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
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 17 Mar 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?
A Phase 4 study testing Piperacillin-tazobactam administered in a prolonged infusion and Piperacillin-tazobactam administered in a standard infusion in people with Infections and Obesity and Obesity-related Medical Conditions, run by CR-CSSS Champlain-Charles-Le Moyne at 1 site in Canada.
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 5 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 17 Mar 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of adherence to the sampling protocol (time frame: At 24 hours of treatment of piperacillin-tazobactam after randomization). The study lists 4 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 17 Mar 2026.