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

Primary Purpose

Decompensated Cirrhosis, Bacterial Infections

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Conventional antibiotic strategies
Regimens guided by epidemiological surveillance
Sponsored by
Eva Bonfill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional antibiotic strategies

    Regimens guided by epidemiological surveillance

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Probability of antibiotic resistance development during hospitalization in both treatment arms.
    Measured by the appearance of new colonizations and/or infections by MDROs.
    Rate of antibiotic resistance development during hospitalization in both treatment arms.
    Measured by the appearance of new colonizations and/or infections by MDROs.
    Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.
    Measured by the appearance of new colonications by MDROs.
    Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.
    Measured by the appearance of new colonications by MDROs.
    Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.
    Measured by the appearance of new infections by MDROs.
    Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.
    Measured by the appearance of new infections by MDROs.
    Infection resolution rate with initial and final strategies in both treatment arms.
    Measured by the number of infections resolution with initial strategies or final strategies.
    Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.
    Measured by the result of ACLF score. Minimum ACLF score: 6 points. Maximum ACLF score: 18 points. Higher scores means a worse result.
    Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.
    Measured by the result of MELD score. Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores means a worse result.
    Evolution of score Child-Pugh in both treatment arms.
    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.
    Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.
    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.
    Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.
    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.
    Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.
    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.
    Days of admission to the ICU if needed.
    Measured by the days of admission to the ICU.
    Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
    Measured by the days of life support.
    Days of hospital stay
    Measured by the days of hospital stay.
    Number of rehospitalizations.
    Measured by the number of rehospitalizations.
    Antibiotics consumption
    Measured by the days of antibiotics consumption.
    Antibiotics consumption
    Measured by dose of antibiotics.
    Antibiotics consumption
    Measured by type of antibiotics.
    Health costs
    Measured by the cost of antibiotic, cost of hospital/ICU stay and of organ support(s).
    Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
    Measured by the number of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
    Hospital survival
    Number of survival participants
    28-day survival
    Number of survival participants

    Full Information

    First Posted
    February 15, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Eva Bonfill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05783661
    Brief Title
    Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
    Acronym
    SURVIC
    Official Title
    Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eva Bonfill

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Decompensated Cirrhosis, Bacterial Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will recieve: Antibiotic regimens guided by colonization/epidemiological surveillance. Conventional antibiotic regimens.
    Masking
    None (Open Label)
    Masking Description
    The study treatment is not blinded, however the rectal and nasal swabs of the control group will be blinded to the investigator and the participant. In all participants, microbiology department will immediately process the samples (swabs) in order to identify a potential colonization by MDR bacteria. Results will be available in the SAP system in patients randomized to the surveillance group but will remained blinded for the clinical investigators in the control group. Blinding will be broken when the patient completes the follow-up period (28 days).
    Allocation
    Randomized
    Enrollment
    198 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional antibiotic strategies
    Arm Type
    Active Comparator
    Arm Description
    The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona.
    Arm Title
    Regimens guided by epidemiological surveillance
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional antibiotic strategies
    Intervention Description
    Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
    Intervention Type
    Other
    Intervention Name(s)
    Regimens guided by epidemiological surveillance
    Intervention Description
    Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
    Primary Outcome Measure Information:
    Title
    Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
    Description
    Measured by the appearance of new colonizations and/or infections by MDROs.
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Probability of antibiotic resistance development during hospitalization in both treatment arms.
    Description
    Measured by the appearance of new colonizations and/or infections by MDROs.
    Time Frame
    During hospitalization (until discharge), assessed up to day 28.
    Title
    Rate of antibiotic resistance development during hospitalization in both treatment arms.
    Description
    Measured by the appearance of new colonizations and/or infections by MDROs.
    Time Frame
    During hospitalization (until discharge), assessed up to day 28.
    Title
    Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.
    Description
    Measured by the appearance of new colonications by MDROs.
    Time Frame
    During hospitalization (until discharge), assessed up to day 28 and at 28 days.
    Title
    Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.
    Description
    Measured by the appearance of new colonications by MDROs.
    Time Frame
    During hospitalization (until discharge), assessed up to day 28 and at 28 days.
    Title
    Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.
    Description
    Measured by the appearance of new infections by MDROs.
    Time Frame
    During hospitalization (until discharge), assessed up to day 28 and at 28 days.
    Title
    Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.
    Description
    Measured by the appearance of new infections by MDROs.
    Time Frame
    During hospitalization (until discharge), assessed up to day 28 and at 28 days.
    Title
    Infection resolution rate with initial and final strategies in both treatment arms.
    Description
    Measured by the number of infections resolution with initial strategies or final strategies.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.
    Description
    Measured by the result of ACLF score. Minimum ACLF score: 6 points. Maximum ACLF score: 18 points. Higher scores means a worse result.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.
    Description
    Measured by the result of MELD score. Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores means a worse result.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Evolution of score Child-Pugh in both treatment arms.
    Description
    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.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.
    Description
    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.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.
    Description
    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.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.
    Description
    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.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Days of admission to the ICU if needed.
    Description
    Measured by the days of admission to the ICU.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
    Description
    Measured by the days of life support.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Days of hospital stay
    Description
    Measured by the days of hospital stay.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Number of rehospitalizations.
    Description
    Measured by the number of rehospitalizations.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Antibiotics consumption
    Description
    Measured by the days of antibiotics consumption.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Antibiotics consumption
    Description
    Measured by dose of antibiotics.
    Time Frame
    Through study completion, an average of 28 days.
    Title
    Antibiotics consumption
    Description
    Measured by type of antibiotics.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Health costs
    Description
    Measured by the cost of antibiotic, cost of hospital/ICU stay and of organ support(s).
    Time Frame
    Through study completion, an average of 28 days
    Title
    Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
    Description
    Measured by the number of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
    Time Frame
    Through study completion, an average of 28 days
    Title
    Hospital survival
    Description
    Number of survival participants
    Time Frame
    During hospitalization (until discharge), assessed up to day 28.
    Title
    28-day survival
    Description
    Number of survival participants
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eva Bonfill
    Phone
    +34 932275400
    Ext
    4198
    Email
    bonfill@recerca.clinic.cat

    12. IPD Sharing Statement

    Learn more about this trial

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

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