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Study of Temocillin and Meropenem for Patients with Infections Caused by Resistant Enterobacteriaceae

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What is this trial about?

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

This clinical study focuses on examining two treatments for infections caused by certain bacteria known as Enterobacteriaceae. These bacteria have developed resistance to a group of antibiotics called third-generation cephalosporins, making treatment more challenging. The study will investigate how effective and safe the antibiotic Temocillin is compared to another antibiotic, Meropenem, in treating these infections.

Infections caused by these resistant bacteria can lead to serious health conditions, such as bacteraemia — a condition where bacteria enter the bloodstream. The study aims to determine if Temocillin is as effective (non-inferior) as Meropenem in treating these infections. The collected data will help assess whether Temocillin could be a viable option for patients.

Participants in the study will receive one of these medications intravenously, meaning they are administered directly into the bloodstream. The treatment will last up to 14 days, with the goal of evaluating overall success, safety, and any complications that might arise during the treatment period. The study also examines aspects such as hospital stay, therapy duration, and the occurrence of any side effects or new infections.

The research process

The trial runs in 5 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 an adult patient with a specific type of infection and having signed the informed consent.

    A negative pregnancy test is required for patients who could potentially become pregnant.

  2. Step 2

    Randomization

    Patients are randomly assigned to receive either temocillin or meropenem for treatment.

    Both medications are administered through an intravenous route.

  3. Step 3

    Treatment administration

    The treatment involves the administration of the assigned medication for a minimum of 4 days, or 3 days if prior treatment was appropriate.

    The duration of therapy should not exceed 14 days unless necessary.

  4. Step 4

    Monitoring and evaluation

    Patients are monitored for clinical success, which includes being alive at day 28, no need to change the medication due to adverse events, and no recurrence of infection.

    Secondary evaluations include monitoring for any adverse events, resistance development, and changes in health status.

  5. Step 5

    Follow-up

    Follow-up assessments are conducted up to day 28 to ensure the absence of infection recurrence and to evaluate overall health outcomes.

    Additional exploratory and exposure variables may be assessed, such as serum levels of temocillin and changes in health scores for patients over 70 years of age.

Who can join the trial?

8 criteria

  • Hospitalized adult patients who are 18 years or older.
  • Patients with a blood infection (bacteremia) caused by a type of bacteria called Enterobacterales. This means the bacteria is found in the blood.
  • Patients can have an infection caused by more than one type of Enterobacterales bacteria, as long as at least one type is resistant to certain antibiotics called third-generation cephalosporins. These antibiotics include cefotaxime, ceftriaxone, and ceftazidime.
  • The bacteria must be resistant to third-generation cephalosporins, which means these antibiotics do not work well against the bacteria.
  • The bacteria must be sensitive to the antibiotics temocillin and meropenem. This means these antibiotics can effectively treat the bacteria.
  • Patients must need to continue receiving medicine through a vein (intravenous treatment) for at least 4 days after being chosen for the study, or 3 days if they were already receiving the right treatment before being chosen.
  • Patients must agree to participate by signing a document called an informed consent.
  • Patients who can become pregnant must have a negative pregnancy test.

Who cannot join the trial?

10 criteria

  • Patients who have allergies to the study medications cannot participate.
  • Individuals with severe liver or kidney problems are excluded.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Patients who are currently participating in another clinical trial cannot take part.
  • Individuals with a history of drug or alcohol abuse may be excluded.
  • Patients with certain heart conditions might not be eligible.
  • Anyone with a compromised immune system, meaning their body's defense against infections is weakened, may not be able to participate.
  • Children under the age of 18 are not eligible for this study.
  • Patients who have had a recent major surgery might be excluded.
  • Individuals with a history of certain types of cancer may not be eligible.
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Investigated drugs

  • Temocillin

    is an antibiotic used in this trial to treat bloodstream infections caused by bacteria that are resistant to certain other antibiotics. The study aims to show that temocillin is as effective and safe as other antibiotics called carbapenems for treating these specific infections.

  • Meropenem

    is another antibiotic used in the trial. It belongs to a group of antibiotics known as carbapenems, which are often used to treat serious infections caused by bacteria that are resistant to other antibiotics. In this study, meropenem is used as a comparison to evaluate the effectiveness and safety of temocillin.

What is already known about the treatment

Temocillin – Temocillin is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials to assess its effectiveness compared to carbapenems for treating bloodstream infections caused by bacteria resistant to certain antibiotics. The main therapeutic use of temocillin is for infections caused by Enterobacteriaceae, particularly those resistant to third-generation cephalosporins. At the molecular level, temocillin works by inhibiting the synthesis of bacterial cell walls, which is essential for bacterial growth and survival. It is classified as a beta-lactam antibiotic, specifically a penicillin derivative.

Investigated diseases

Infections due to Enterobacteriaceae – These infections are caused by a group of bacteria known as Enterobacteriaceae, which are commonly found in the intestines of humans and animals. They can lead to a variety of infections, including urinary tract infections, bloodstream infections, and pneumonia. The bacteria can become resistant to antibiotics, making infections difficult to treat. These infections often occur in healthcare settings, particularly affecting individuals with weakened immune systems. The bacteria can spread through direct contact or contaminated surfaces. Symptoms may vary depending on the site of infection but often include fever, chills, and signs of inflammation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508440-21-00Protocol codeASTARTÉEstimated enrolment334 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).