Comparing antibiotic strategies for infected patients with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares conventional antibiotic treatments with those guided by epidemiological surveillance in patients suffering from decompensated cirrhosis and bacterial infections. The study aims to determine which approach is more effective in managing infections in this vulnerable population. Patients aged 18 and older with acute decompensation and a bacterial infection will be included, while those with certain exclusions, such as critically ill patients or those with advanced malignancies, will not be eligible.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cirrhotic patients with acute decompensation aged ≥18 years.
2. Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).
3. Signed informed consent or consent given by their legal representatives or close relatives.

Exclusion Criteria:

1. Bacterial infection lasting for \> 48 hours.
2. Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.
3. MDR colonization or infection in the last month.
4. Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
5. Pregnant and/or breast-feeding woman.
6. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.

Where it's running

• Eva Bonfill
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Eva Bonfill
• Email: bonfill@recerca.clinic.cat
• Phone: +34 932275400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.