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

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What is this study about?

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.

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 randomization

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

Both medications are administered through an intravenous route.

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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario Torrecardenas Almeria Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario De Cruces Barakaldo Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Lucus Augusti Lugo Spain
Hospital Alvaro Cunqueiro Vigo Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.12.2020

Trial locations

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.

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 ID:
2023-508440-21-00
Protocol code:
ASTARTÉ
NCT ID:
NCT04478721
Trial Phase:
Therapeutic confirmatory (Phase III)

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