Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ):randomised, pragmatic trial
This research study, called ASTARTÉ, is looking at the best way to treat serious blood infections (bacteraemia) caused by a type of bacteria called Enterobacterales. These bacteria are often resistant to common antibiotics. The study compares two main antibiotics, temocillin and meropenem, and also considers ertapenem. It wants to find out which treatment is most effective in helping patients recover fully. Researchers will be looking at several things to decide if a treatment is successful. This includes how well patients get better clinically, if they are still alive after 28 days, if they can complete the treatment without problems, and if the infection doesn't come back. The hope is to improve how we treat these difficult infections and help patients have better outcomes.
At a glance
What is this study about?
Imagine you have a serious infection in your blood caused by bacteria that are tricky to treat, perhaps because they've learned to resist some common antibiotics. This study, called ASTARTÉ, is trying to find the best way to fight these specific types of infections. Doctors sometimes use strong antibiotics, but we don't always know which one works best, causes fewest problems, and helps people recover most completely.
The ASTARTÉ study is comparing two main antibiotics: temocillin and meropenem. Another antibiotic, ertapenem, is also involved. They want to see which one leads to the most successful recovery. Success in this study means several things: getting better from the infection, staying well and alive after 28 days, not needing to stop the treatment early due to side effects, not having the infection come back, and not needing to take the antibiotics for longer than planned.
This research is important because it could help doctors understand which antibiotic is the most effective and safest choice for these difficult infections. By finding better treatments, patients could get better quicker, have fewer complications, and spend less time in the hospital. This study is in a late stage of testing (Phase III), meaning previous research has already suggested these treatments could be helpful, and now doctors want to confirm it in a larger group of people.
Key takeaways
- Compares antibiotics for difficult blood infections.
- Aims to find the most effective and safest treatment.
- Focuses on patient recovery and avoiding complications.
- Participation involves receiving one of the study treatments.
- Close monitoring of health and treatment response for 28 days.
- Helps improve future treatment for similar infections.
Who may be eligible?
This study is looking for adults aged 18 and older. Both men and women can take part. To be eligible, you would need to have a specific type of blood infection caused by Enterobacterales bacteria, which are resistant to certain antibiotics.
Your doctors would check your medical history to make sure that participating in the study would be safe and appropriate for you, considering your overall health and any other medical conditions you might have. You would not be able to participate if the study treatments might not be suitable for your specific situation.
- Are you 18 years old or older?
- Do you have a blood infection caused by specific bacteria called Enterobacterales?
- Are these bacteria known to be resistant to certain antibiotics?
- Are you able to undergo regular medical check-ups and monitoring?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive one of the study antibiotics (temocillin, meropenem, or ertapenem) as part of your treatment. Your doctors and the study team would carefully monitor your health and how you respond to the treatment. This would involve regular check-ups, potentially blood tests, and assessments of your symptoms.
They would keep track of whether your infection is getting better, if you experience any side effects, and if you need to stay in the hospital. The main period of observation would be for 28 days after starting the treatment, to see if the treatment was successful, if the infection recurred, or if any new infections developed. There would also be follow-up to ensure your continued well-being.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What kind of infection is this study focused on?
It's for serious blood infections caused by specific bacteria called Enterobacterales, especially those that are hard to treat with common antibiotics.
What antibiotics are being studied?
The main antibiotics being compared are temocillin and meropenem, with ertapenem also being considered.
How long will I be involved in the study?
The main period for checking the treatment's success and your recovery is 28 days, though you will be monitored throughout your treatment and potentially beyond.
Will I know which antibiotic I'm getting?
Because this is a clinical trial, it's possible you might not know which specific study antibiotic you are receiving right away, as this helps ensure fair comparison.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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