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

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

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

Conditions
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Decompensated Cirrhosis, Bacterial Infections

Intervention / Treatment
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* Other: Conventional antibiotic strategies
* Other: Regimens guided by epidemiological surveillance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will recieve: Antibiotic regimens guided by colonization/epidemiological surveillance. Conventional antibiotic regimens.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional antibiotic strategies<br>The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona. | Other: Conventional antibiotic strategies<br>* Treatment according to the local guidelines of the Hospital Clinic de Barcelona.<br>|
| Experimental: Regimens guided by epidemiological surveillance<br>The experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance. | Other: Regimens guided by epidemiological surveillance<br>* Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of antibiotic resistance development during hospitalization in both treatment arms. | Measured by the appearance of new colonizations and/or infections by MDROs. | During hospitalization (until discharge), assessed up to day 28. | 
| Rate of antibiotic resistance development during hospitalization in both treatment arms. | Measured by the appearance of new colonizations and/or infections by MDROs. | During hospitalization (until discharge), assessed up to day 28. | 
| Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms. | Measured by the appearance of new colonications by MDROs. | During hospitalization (until discharge), assessed up to day 28 and at 28 days. | 
| Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms. | Measured by the appearance of new colonications by MDROs. | During hospitalization (until discharge), assessed up to day 28 and at 28 days. | 
| Rate of MDRO infection during hospitalization and at 28 days in both treatment arms. | Measured by the appearance of new infections by MDROs. | During hospitalization (until discharge), assessed up to day 28 and at 28 days. | 
| Probability of MDRO infection during hospitalization and at 28 days in both treatment arms. | Measured by the appearance of new infections by MDROs. | During hospitalization (until discharge), assessed up to day 28 and at 28 days. | 
| 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. | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| Days of admission to the ICU if needed. | Measured by the days of admission to the ICU. | Through study completion, an average of 28 days | 
| Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed. | Measured by the days of life support. | Through study completion, an average of 28 days | 
| Days of hospital stay | Measured by the days of hospital stay. | Through study completion, an average of 28 days | 
| Number of rehospitalizations. | Measured by the number of rehospitalizations. | Through study completion, an average of 28 days | 
| Antibiotics consumption | Measured by the days of antibiotics consumption. | Through study completion, an average of 28 days | 
| Antibiotics consumption | Measured by dose of antibiotics. | Through study completion, an average of 28 days. | 
| Antibiotics consumption | Measured by type of antibiotics. | Through study completion, an average of 28 days | 
| Health costs | Measured by the cost of antibiotic, cost of hospital/ICU stay and of organ support(s). | Through study completion, an average of 28 days | 
| 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. | Through study completion, an average of 28 days | 
| Hospital survival | Number of survival participants | During hospitalization (until discharge), assessed up to day 28. | 
| 28-day survival | Number of survival participants | 28 days |