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

Bacterial Infections Clinical Trial

— SURVIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783661
• Other study ID #: 2022-001858-33
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: Eva Bonfill
• Phone: +34 932275400
• Email: bonfill[@]recerca.clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cirrhotic patients with acute decompensation aged =18 years.

2. Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).

3. Signed informed consent or consent given by their legal representatives or close relatives.

Exclusion Criteria:

1. Bacterial infection lasting for > 48 hours.

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

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

4. Pregnant and/or breast-feeding woman.

5. 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.

Related Conditions & MeSH terms

• Bacterial Infections
• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• Conventional antibiotic strategies
Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
• Regimens guided by epidemiological surveillance
Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eva Bonfill

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Days of hospital stay	Measured by the days of hospital stay.	Through study completion, an average of 28 days
Secondary	Number of rehospitalizations.	Measured by the number of rehospitalizations.	Through study completion, an average of 28 days
Secondary	Antibiotics consumption	Measured by the days of antibiotics consumption.	Through study completion, an average of 28 days
Secondary	Antibiotics consumption	Measured by dose of antibiotics.	Through study completion, an average of 28 days.
Secondary	Antibiotics consumption	Measured by type of antibiotics.	Through study completion, an average of 28 days
Secondary	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
Secondary	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
Secondary	Hospital survival	Number of survival participants	During hospitalization (until discharge), assessed up to day 28.
Secondary	28-day survival	Number of survival participants	28 days