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

ConditionsDecompensated CirrhosisBacterial Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEva Bonfill

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Bacterial infection lasting for > 48 hours.

Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.

MDR colonization or infection in the last month.

Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional antibiotic strategies

    Other intervention

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

  • Regimens guided by epidemiological surveillance

    Other intervention

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

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Conventional antibiotic strategiesActive comparator 1 intervention
Group B: Regimens guided by epidemiological surveillanceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.

Measured by the appearance of new colonizations and/or infections by MDROs.

Time frame
28 days

Secondary outcomes

1

Probability of antibiotic resistance development during hospitalization in both treatment arms.

Measured by the appearance of new colonizations and/or infections by MDROs.

Time frame
During hospitalization (until discharge), assessed up to day 28.
2

Rate of antibiotic resistance development during hospitalization in both treatment arms.

Measured by the appearance of new colonizations and/or infections by MDROs.

Time frame
During hospitalization (until discharge), assessed up to day 28.
3

Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.

Measured by the appearance of new colonications by MDROs.

Time frame
During hospitalization (until discharge), assessed up to day 28 and at 28 days.
4

Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.

Measured by the appearance of new colonications by MDROs.

Time frame
During hospitalization (until discharge), assessed up to day 28 and at 28 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eva Bonfill

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Sponsor institution

Source ClinicalTrials.gov
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