Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)

Launched by EVA BONFILL · Mar 13, 2023

Keywords

ClinConnect Summary

The SURVIC_STUDY is a clinical trial designed to compare two different approaches to treating bacterial infections in patients with a serious liver condition called cirrhosis. The study aims to find out whether using standard antibiotic treatments or treatments guided by local infection data leads to better outcomes for patients. This research is particularly important for those with decompensated cirrhosis, which means their liver is not functioning well and they are at higher risk for infections.

To be eligible for this trial, participants must be at least 18 years old, have been diagnosed with cirrhosis and have a bacterial infection that requires antibiotics. They should also be able to provide consent for themselves or have a legal representative who can do so. However, patients who have had their infection for more than 48 hours, are critically ill, pregnant, or cannot give consent are not eligible. Those who join the trial can expect to be carefully monitored for their infection and receive treatment according to one of the two strategies being studied. This research will help improve the management of infections in patients with cirrhosis, potentially leading to better care in the future.

Gender

ALL

Eligibility criteria

• 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. Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
• • 4. Pregnant and/or breast-feeding woman.
• • 5. 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.