Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
Study Details
Study Description
Brief Summary
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Conventional antibiotic strategies The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona. |
Other: Conventional antibiotic strategies
Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
|
| Experimental: Regimens guided by epidemiological surveillance 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
Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
|
Outcome Measures
Primary Outcome Measures
- Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days. [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. [During hospitalization (until discharge), assessed up to day 28.]
Measured by the appearance of new colonizations and/or infections by MDROs.
- Rate of antibiotic resistance development during hospitalization in both treatment arms. [During hospitalization (until discharge), assessed up to day 28.]
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. [During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
Measured by the appearance of new colonications by MDROs.
- Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms. [During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
Measured by the appearance of new colonications by MDROs.
- Rate of MDRO infection during hospitalization and at 28 days in both treatment arms. [During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
Measured by the appearance of new infections by MDROs.
- Probability of MDRO infection during hospitalization and at 28 days in both treatment arms. [During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
Measured by the appearance of new infections by MDROs.
- Infection resolution rate with initial and final strategies in both treatment arms. [Through study completion, an average of 28 days]
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. [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.
- Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms. [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.
- Evolution of score Child-Pugh in both treatment arms. [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.
- Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms. [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.
- Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms. [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.
- Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms. [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.
- Days of admission to the ICU if needed. [Through study completion, an average of 28 days]
Measured by the days of admission to the ICU.
- Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed. [Through study completion, an average of 28 days]
Measured by the days of life support.
- Days of hospital stay [Through study completion, an average of 28 days]
Measured by the days of hospital stay.
- Number of rehospitalizations. [Through study completion, an average of 28 days]
Measured by the number of rehospitalizations.
- Antibiotics consumption [Through study completion, an average of 28 days]
Measured by the days of antibiotics consumption.
- Antibiotics consumption [Through study completion, an average of 28 days.]
Measured by dose of antibiotics.
- Antibiotics consumption [Through study completion, an average of 28 days]
Measured by type of antibiotics.
- Health costs [Through study completion, an average of 28 days]
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. [Through study completion, an average of 28 days]
Measured by the number of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
- Hospital survival [During hospitalization (until discharge), assessed up to day 28.]
Number of survival participants
- 28-day survival [28 days]
Number of survival participants
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eva Bonfill
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-001858-33