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Study on Piperacillin-Tazobactam and Temocillin for Treating Severe Infections in ICU Patients with ESBL-Producing Gram-Negative Bacteria

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on treating severe infections caused by a specific type of bacteria known as extended-spectrum beta-lactamase-producing Gram-negative Enterobacteriaceae. These infections are often found in patients who are in the intensive care unit (ICU). The study is exploring the use of two alternative treatments to a commonly used antibiotic called carbapenem. The treatments being tested are piperacillin/tazobactam and temocillin. The goal is to see if these alternatives are just as effective as carbapenem in treating these severe infections.

Participants in the study will receive one of the treatments, which are administered through an infusion, a method where the medication is delivered directly into the bloodstream. The study will last for a maximum of 21 days, during which the health and recovery of the participants will be closely monitored. The main focus is to compare the effectiveness of the treatments in terms of survival rates and to ensure that the alternative treatments do not lead to higher mortality compared to the standard carbapenem treatment.

Throughout the study, researchers will also observe other factors such as the length of stay in the ICU and hospital, any side effects from the medications, and the overall recovery process. The study aims to provide valuable information on whether these alternative treatments can be safely used in place of carbapenem for patients with these severe infections.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. This includes being 18 years or older, hospitalized in the intensive care unit (ICU) with a severe infection caused by a specific type of bacteria known as ESBL-producing Enterobacteriaceae.

    Consent is required from the patient or a legal representative. In emergency situations, consent may be obtained later.

  2. Step 2

    Randomization

    Patients are randomly assigned to receive one of the following treatments: meropenem, piperacillin/tazobactam, or temocillin.

    The goal is to compare the effectiveness of these treatments in managing the infection.

  3. Step 3

    Treatment administration

    The assigned medication is administered through an infusion, which is a method of delivering medication directly into the bloodstream.

    The specific dosage and frequency depend on the assigned treatment and the patient's condition.

  4. Step 4

    Monitoring and assessment

    Throughout the treatment, the patient's health is closely monitored. This includes checking for any side effects or allergic reactions to the medication.

    The effectiveness of the treatment is assessed by observing the patient's recovery and any changes in their condition.

  5. Step 5

    Follow-up evaluations

    After 30 days, the patient's health is evaluated to determine the outcome of the treatment. This includes checking for any relapse of the infection or other complications.

    Additional follow-up occurs at 90 days to assess long-term outcomes, such as any new infections or changes in health status.

  6. Step 6

    Completion of the study

    The study concludes with a final assessment of the patient's health and the overall effectiveness of the treatment.

    The information gathered contributes to understanding the best treatment options for similar infections in the future.

Who can join the trial?

6 criteria

  • Patients must be **18 years or older**.
  • Must be **hospitalized in the ICU** (Intensive Care Unit).
  • Have a **severe infection**. This can include infections with or without **sepsis** or **septic shock**. Sepsis is a serious condition where the body responds to an infection in a way that can damage its own tissues. Septic shock is a severe form of sepsis that can cause dangerously low blood pressure. These conditions must be confirmed within 24 hours from the day the infection is diagnosed.
  • The infection must be caused by a specific type of bacteria called **ESBL-producing Enterobacteriaceae**. These bacteria should be treatable with a medicine called **meropenem** and either **piperacillin/tazobactam** or **temocillin**. The bacteria's sensitivity to these medicines is measured by a test called **minimum inhibitory concentration**, which should be less than or equal to 8 mg/L.
  • Must have **signed informed consent**. This means the patient, or someone legally allowed to make decisions for them, agrees to participate in the study. If the patient cannot give consent and no legal representative is available, the study may proceed with emergency inclusion, but consent will be sought as soon as possible.
  • Must be **affiliated with social security**, but not under a specific program called AME.

Who cannot join the trial?

5 criteria

  • Patients who are not hospitalized in the ICU (Intensive Care Unit).
  • Patients who do not have a severe infection caused by ESBL-producing Enterobacteriaceae. This refers to a type of bacteria that is resistant to many antibiotics.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of a vulnerable population.
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Investigated drugs

  • Piperacillin-tazobactam

    is a combination antibiotic used to treat severe infections. It works by stopping the growth of bacteria. In this trial, it is being tested as an alternative to carbapenems for treating serious infections caused by certain resistant bacteria in patients in the intensive care unit.

  • Temocillin

    is an antibiotic that is used to treat infections caused by specific types of bacteria. It is being evaluated in this trial as another alternative to carbapenems for treating severe infections in patients in the intensive care unit.

What is already known about the treatment

  • Piperacillin-tazobactam

    This medication is administered intravenously and is used in hospitals, particularly in intensive care units, to treat severe infections caused by certain bacteria. It is currently being studied as an alternative to carbapenems for treating infections caused by ESBL-producing Enterobacteriaceae. The main therapeutic indication is for severe bacterial infections, especially in patients in critical care. Piperacillin-tazobactam works by inhibiting bacterial cell wall synthesis, effectively killing the bacteria. It is classified as a combination antibiotic, consisting of a penicillin derivative and a beta-lactamase inhibitor.

  • Temocillin

    This medication is also administered intravenously and is used in hospital settings to treat severe bacterial infections. It is being evaluated as a carbapenem-sparing option for infections caused by ESBL-producing Enterobacteriaceae in intensive care units. The primary therapeutic use is for severe infections in critically ill patients. Temocillin acts by inhibiting bacterial cell wall synthesis, which leads to the destruction of the bacteria. It is classified as a beta-lactam antibiotic, specifically a penicillin derivative.

Investigated diseases

ESBL-producing Enterobacteriaceae Infection – This infection is caused by bacteria that produce an enzyme called extended-spectrum beta-lactamase (ESBL), which makes them resistant to many common antibiotics. These bacteria are often found in the intestines but can cause severe infections if they spread to other parts of the body, especially in hospitalized patients. The infection can lead to symptoms such as fever, chills, and signs of inflammation in the affected area. In severe cases, it can cause bloodstream infections, urinary tract infections, or pneumonia. The progression of the disease can be rapid, especially in individuals with weakened immune systems, such as those in intensive care units (ICUs). Managing the infection often requires careful selection of antibiotics due to the bacteria's resistance profile.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511866-36-00Protocol codeAPHP211034Estimated enrolment600 patientsSponsorAssistance Publique Hopitaux De Paris

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