RecruitingPhase 4NCT05783661

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

Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis


Sponsor

Eva Bonfill

Enrollment

198 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

  • Bacterial infection lasting for > 48 hours.
  • Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.
  • Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
  • Pregnant and/or breast-feeding woman.
  • 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.

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Interventions

OTHERConventional antibiotic strategies

Treatment according to the local guidelines of the Hospital Clinic de Barcelona.

OTHERRegimens guided by epidemiological surveillance

Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.


Locations(1)

Eva Bonfill

Barcelona, Spain

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NCT05783661


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