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AuthorisedTherapeutic use (Phase IV)Interventional

Randomized controlled trial comparing conventional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.

This research is for people in hospital with advanced liver disease (cirrhosis) who have developed a bacterial infection. Doctors are comparing two ways of giving antibiotics: the usual approach versus an approach guided by information about which germs are common in that area. The main goal is to see which method leads to fewer patients developing antibiotic resistance within 28 days. Antibiotic resistance means that germs become harder to treat with standard medications. They will also look at how quickly infections clear up, how long people stay in hospital, and how their liver disease scores change. This study aims to find the best way to treat infections in these vulnerable patients.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Enrolment target
198
Start
19 Dec 2024

What is this study about?

Imagine you're in hospital with a serious liver condition called cirrhosis, and you get a bacterial infection. Doctors want to treat it effectively, but they also want to prevent the germs from becoming resistant to antibiotics. When germs become resistant, the medicines stop working, making future infections much harder to treat.

This study is looking at two ways of choosing antibiotics for patients like you. One way is the standard treatment that doctors typically use. The other way involves using up-to-date information about what types of germs are common in the hospital or community at that time. The idea is that if doctors know which germs are likely to be causing the infection, they might be able to pick the most effective antibiotic straight away, which could help stop resistance from developing.

The main thing researchers want to find out is whether one of these approaches leads to fewer people developing antibiotic resistance within 28 days. They'll also be tracking other important things like how well the infection clears up, how long people need to stay in hospital, if they need intensive care, and how their overall health and liver scores change. They'll also look at the costs involved and any side effects from the antibiotics.

Key takeaways

  • This study compares two ways of choosing antibiotics for people with advanced liver disease and an infection.
  • The main goal is to find out which method leads to less antibiotic resistance.
  • It also looks at how well infections clear up, hospital stays, and overall health.
  • Participants will receive standard medical care and specific antibiotics as part of the study.
  • The study aims to improve treatment for vulnerable patients and prevent antibiotic resistance.
  • Participation involves monitoring over at least 28 days.

Who may be eligible?

This study is looking for particular patients to take part. You might be suitable if you are an adult, at least 18 years old, and are currently in hospital.

You would also need to have advanced liver disease, called decompensated cirrhosis. On top of that, you must have been diagnosed with a bacterial infection that started within the last 48 hours. The study includes both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you currently in hospital?
  3. Do you have advanced liver disease (decompensated cirrhosis)?
  4. Have you been diagnosed with a bacterial infection that started in the last two days?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive antibiotics, likely Norfloxacin, as part of your treatment. This is a common antibiotic. The doctors will either choose your antibiotic based on standard practice or by using special information about local germs. You would continue to receive care for your infection and liver condition as usual.

Researchers will regularly check for signs of antibiotic resistance, usually through samples (like blood or urine tests) collected over your hospital stay and at 28 days after starting treatment. They will also keep track of your overall health, how long you stay in hospital, and how your liver condition is progressing. The total duration of your participation in the study for monitoring purposes would be at least 28 days.

Potential risks and benefits

Taking part might help us learn more about the best ways to treat infections in people with liver disease and reduce antibiotic resistance, potentially benefiting future patients. You might also receive closer monitoring by the medical team. As with all medications, antibiotics can have side effects, which the study team will monitor closely. There's always a chance that a chosen antibiotic may not work as effectively, but your doctors will be watching your progress carefully and will change your treatment if needed. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What is 'advanced liver disease' or 'cirrhosis'?

Cirrhosis is a serious condition where your liver is scarred and damaged, making it harder for it to work properly.

Why is 'antibiotic resistance' a concern?

Antibiotic resistance means that germs learn to fight off the medicines designed to kill them, making infections harder to treat in the future.

Will I get a different type of antibiotic if I join?

You will receive an antibiotic, likely Norfloxacin, but the way your doctor chooses it (either standard or based on local germ information) might be part of the study.

How long will I be involved in the study?

Your participation will be for at least 28 days, during which your health will be monitored, and samples may be collected.

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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