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NCT Number: NCT05783661

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

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

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Key information

Conditions

Decompensated Cirrhosis Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eva Bonfill

Barcelona, 08036, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).
  • 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.

Treatment and study plan

Conventional antibiotic strategies

Other

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

Regimens guided by epidemiological surveillance

Other

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

Primary outcomes

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

    Time frame: 28 days

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

Secondary outcomes

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

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

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

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

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

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

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

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

    Measured by the appearance of new colonications by MDROs.

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

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

    Measured by the appearance of new colonications by MDROs.

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

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

    Measured by the appearance of new infections by MDROs.

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

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

    Measured by the appearance of new infections by MDROs.

  7. Infection resolution rate with initial and final strategies in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the number of infections resolution with initial strategies or final strategies.

  8. Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the result of ACLF score. Minimum ACLF score: 6 points. Maximum ACLF score: 18 points. Higher scores means a worse result.

  9. Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the result of MELD score. Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores means a worse result.

  10. Evolution of score Child-Pugh in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the result of Child -Pugh score. Minimum Child-Pugh score: 5 points. Maximum Child-Pugh score: 15 points. Higher scores means a worse result.

  11. Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the result of CLIF-OF score. Minimum CLIF-OF score: 6 points. Maximum CLIF-OF score: 18 points. Higher scores means a worse result.

  12. Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the result of CLIF-C AD score.

    Minimum CLIF-C AD score: 6 points. Maximum CLIF-C AD score: 18 points. Higher scores means a worse result.

  13. Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.

    Time frame: Through study completion, an average of 28 days

    Measured by the result of CLIF-C ACLF score. Minimum CLIF-C ACLF score: 6 points. Maximum CLIF-C ACLF score: 18 points. Higher scores means a worse result.

  14. Days of admission to the ICU if needed.

    Time frame: Through study completion, an average of 28 days

    Measured by the days of admission to the ICU.

  15. Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.

    Time frame: Through study completion, an average of 28 days

    Measured by the days of life support.

  16. Days of hospital stay

    Time frame: Through study completion, an average of 28 days

    Measured by the days of hospital stay.

  17. Number of rehospitalizations.

    Time frame: Through study completion, an average of 28 days

    Measured by the number of rehospitalizations.

  18. Antibiotics consumption

    Time frame: Through study completion, an average of 28 days

    Measured by the days of antibiotics consumption.

  19. Antibiotics consumption

    Time frame: Through study completion, an average of 28 days.

    Measured by dose of antibiotics.

  20. Antibiotics consumption

    Time frame: Through study completion, an average of 28 days

    Measured by type of antibiotics.

  21. Health costs

    Time frame: Through study completion, an average of 28 days

    Measured by the cost of antibiotic, cost of hospital/ICU stay and of organ support(s).

  22. Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.

    Time frame: Through study completion, an average of 28 days

    Measured by the number of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.

  23. Hospital survival

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

    Number of survival participants

  24. 28-day survival

    Time frame: 28 days

    Number of survival participants

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Bonfill

CONTACT

[email protected]

+34 932275400 ext. 4198

Sponsors and collaborators

Lead sponsor

Eva Bonfill

Other

Registry information

Official study title

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

Acronym: SURVIC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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