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

Eva Bonfill

Status and phase: Enrolling; Phase 4

Conditions: Decompensated Cirrhosis; Bacterial Infections

Treatments: Other: Regimens guided by epidemiological surveillance; Other: Conventional antibiotic strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT05783661

2022-001858-33

Details and patient eligibility

About

Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Conventional antibiotic strategies

Active Comparator group

Description:

The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona.

Treatment:

Other: Conventional antibiotic strategies

Regimens guided by epidemiological surveillance

Experimental group

Description:

The experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.

Treatment:

Other: Regimens guided by epidemiological surveillance