Antibiotic ProphylaxisPROPHTAZNCT07558681
Perioperative Pharmacokinetic/Pharmacodynamic Target Attainment of Piperacillin During Major Hepatic and Pancreatic Surgery
An observational study of Antibiotic Prophylaxis and Pancreatic Surgey, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Hepatic and pancreatic surgeries are associated with a high risk of surgical site infections, particularly in patients with preoperative biliary drainage, which is frequently associated with bacterial colonization of bile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Prophylaxis, Pancreatic Surgey, Hepatic Surgery
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Sep 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult patients undergoing elective hepatic or pancreatic surgery at a tertiary care university hospital (CHRU Nancy, France). Eligible patients are those receiving perioperative antibiotic prophylaxis with piperacillin/tazobactam according to current clinical guidelines, particularly in the context of preoperative biliary drainage or high risk of biliary contamination. These patients represent a high-risk surgical population for surgical site infections, characterized by complex procedures, potential intraoperative hemodynamic variations, and significant pharmacokinetic variability. Patients are managed in a perioperative setting including the operating room and postoperative admission to a surgical intensive care or intermediate care unit.
Who may be able to join
- Adults > or = to 18 years old
- Scheduled for major hepatic or pancreatic surgery
- Receiving piperacillin/tazobactam as perioperative antibiotic prophylaxis according to guidelines
Who cannot join
- decline to participate
- Known allergy of beta-lactam
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHRU de NANCY
Nancy
- Not yet recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500
Viviane MARTIN, PhD, +33 3155285, v.martin3@chru-nancy.fr
About this study
Official title: PROPHTAZ: Evaluation of Pharmacokinetic/Pharmacodynamic Target Attainment of Piperacillin During Major Hepatic and Pancreatic Surgery, a Prospective Observational Pharmacokinetic Study
Hepatic and pancreatic surgeries are associated with a high risk of surgical site infections, particularly in patients with preoperative biliary drainage, which is frequently associated with bacterial colonization of bile. In this context, perioperative antibiotic prophylaxis is essential, and recent guidelines recommend the use of piperacillin/tazobactam in selected high-risk patients.
However, piperacillin, like other β-lactam antibiotics, exhibits pharmacokinetic variability that may be exacerbated during major surgery due to factors such as fluid shifts, hypoalbuminemia, and changes in volume of distribution. These alterations may result in suboptimal antibiotic exposure during the perioperative period, potentially compromising prophylactic efficacy.
Read more
Despite these concerns, standard dosing regimens remain unchanged across different types of major abdominal surgery, including hepatic and pancreatic procedures, which differ significantly in terms of duration, physiological impact, and intraoperative management.
The PROPHTAZ study is a prospective, single-center observational pharmacokinetic study designed to evaluate whether standard perioperative administration of piperacillin/tazobactam achieves predefined pharmacokinetic/pharmacodynamic (PK/PD) targets in patients undergoing hepatic or pancreatic surgery. The primary objective is to determine the proportion of patients achieving adequate PK/PD exposure during surgery. Secondary objectives include describing perioperative plasma concentrations, assessing pharmacokinetic variability, identifying factors associated with target non-attainment, and comparing outcomes between surgical subgroups.
This study aims to provide clinically relevant data to assess the adequacy of current prophylactic dosing strategies and to support potential optimization of antibiotic administration in high-risk surgical patients.
- Conditions
- Antibiotic Prophylaxis, Pancreatic Surgey, Hepatic Surgery
- Keywords
- PK/PD target atttainment, piperacillin, surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with scheduled pancreatic or major hepatic surgery | Adult patients with scheduled pancreatic surgery or major hepatic receiving piperacillin/tazobactam as antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK/PD target attainment of piperacillin
Proportion of patients achieving the predefined* PK/PD target during the perioperative period
*estimated free concentration of piperacillin (80% of the total concentration) above the MIC of the isolated pathogen from bile samples throughout the surgical procedure (from incision to wound closure)
Measured: 4 hours after the administration of piperacillin
Secondary outcomes (2)
Plasma piperacillin concentration
Total (measured) et free (estimated) concentration of piperacilline throughout at two timepoints: surgical incision and wound closure
Measured: 4 hours after the administration of piperacillin
Factors associated with target attainment
Analysis of clinical and biological covariates associated with pharmacokinetic variability and the achievement of pharmacodynamic targets
Measured: 4 hours after the administration of piperacillin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start25 Sep 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558681
- Sponsor's protocol ID
- 2025PI208
- Acronym
- PROPHTAZ
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPHTAZ: Evaluation of Pharmacokinetic/Pharmacodynamic Target Attainment of Piperacillin During Major Hepatic and Pancreatic Surgery, a Prospective Observational Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT07558681
- Acronym / sponsor ID
- PROPHTAZ / 2025PI208
- Conditions
- Antibiotic Prophylaxis, Pancreatic Surgey, Hepatic Surgery
- Keywords
- PK/PD target atttainment, piperacillin, surgical site infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Apr 2026 (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.
Hepatic and pancreatic surgeries are associated with a high risk of surgical site infections, particularly in patients with preoperative biliary drainage, which is frequently associated with bacterial colonization of bile. In this context, perioperative antibiotic prophylaxis is essential, and recent guidelines recommend the use of piperacillin/tazobactam in selected high-risk patients.
However, piperacillin, like other β-lactam antibiotics, exhibits pharmacokinetic variability that may be exacerbated during major surgery due to factors such as fluid shifts, hypoalbuminemia, and changes in volume of distribution. These alterations may result in suboptimal antibiotic exposure during the perioperative period, potentially compromising prophylactic efficacy.
Despite these concerns, standard dosing regimens remain unchanged across different types of major abdominal surgery, including hepatic and pancreatic procedures, which differ significantly in terms of duration, physiological impact, and intraoperative management.
The PROPHTAZ study is a prospective, single-center observational pharmacokinetic study designed to evaluate whether standard perioperative administration of piperacillin/tazobactam achieves predefined pharmacokinetic/pharmacodynamic (PK/PD) targets in patients undergoing hepatic or pancreatic surgery. The primary objective is to determine the proportion of patients achieving adequate PK/PD exposure during surgery. Secondary objectives include describing perioperative plasma concentrations, assessing pharmacokinetic variability, identifying factors associated with target non-attainment, and comparing outcomes between surgical subgroups.
This study aims to provide clinically relevant data to assess the adequacy of current prophylactic dosing strategies and to support potential optimization of antibiotic administration in high-risk surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with scheduled pancreatic or major hepatic surgery | – | –Adult patients with scheduled pancreatic surgery or major hepatic receiving piperacillin/tazobactam as antibiotic prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing elective hepatic or pancreatic surgery at a tertiary care university hospital (CHRU Nancy, France). Eligible patients are those receiving perioperative antibiotic prophylaxis with piperacillin/tazobactam according to current clinical guidelines, particularly in the context of preoperative biliary drainage or high risk of biliary contamination. These patients represent a high-risk surgical population for surgical site infections, characterized by complex procedures, potential intraoperative hemodynamic variations, and significant pharmacokinetic variability. Patients are managed in a perioperative setting including the operating room and postoperative admission to a surgical intensive care or intermediate care unit.
Key inclusion criteria (3 listed)
- Adults > or = to 18 years old
- Scheduled for major hepatic or pancreatic surgery
- Receiving piperacillin/tazobactam as perioperative antibiotic prophylaxis according to guidelines
Key exclusion criteria (2 listed)
- decline to participate
- Known allergy of beta-lactam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PK/PD target attainment of piperacillin
Time frame: 4 hours after the administration of piperacillin
Proportion of patients achieving the predefined* PK/PD target during the perioperative period *estimated free concentration of piperacillin (80% of the total concentration) above the MIC of the isolated pathogen from bile samples throughout the surgical procedure (from incision to wound closure)
2 secondary outcomes
Plasma piperacillin concentration
Time frame: 4 hours after the administration of piperacillin
Factors associated with target attainment
Time frame: 4 hours after the administration of piperacillin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Prophylaxis and Pancreatic Surgey, run by Central Hospital, Nancy, France at 2 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel NOVY, MD, PhD (+33 383157437, e.novy@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK/PD target attainment of piperacillin (time frame: 4 hours after the administration of piperacillin). 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 2 Oct 2026.