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Are antibiotic doses right for High-Risk surgery patients?

NCT ID NCT07558681

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the usual dose of the antibiotic piperacillin/tazobactam is enough to prevent infections during major liver or pancreas surgery. Researchers will measure antibiotic levels in the blood of 60 adult patients during surgery. The goal is to see if current dosing works or needs to be adjusted for these high-risk procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
piperacillin/tazobactam (antibiotic)
What this could lead to
If successful, this could lead to better antibiotic dosing guidelines for liver and pancreas surgery patients, potentially reducing surgical infections.
What could go wrong
This is a small, early observational study (60 people) that only measures drug levels—it does not test whether infections are actually prevented. Results may not apply to all hospitals or patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults \> or = to 18 years old * Scheduled for major hepatic or pancreatic surgery * Receiving piperacillin/tazobactam as perioperative antibiotic prophylaxis according to guidelines Exclusion Criteria: * decline to participate * Known allergy of beta-lactam

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Conditions

The condition(s) this trial relates to.

Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU de Nancy

    Vandœuvre-lès-Nancy, Lorraine, 54500, France

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