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

Phase 4

Not yet recruiting

• Conditions: Decompensated Cirrhosis; Bacterial Infections

• Registration Number: NCT05783661
• Lead Sponsor: Eva Bonfill

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Start: 2024-08
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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 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.
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.
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).
Hospital survival	During hospitalization (until discharge), assessed up to day 28.	Number of survival participants
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.
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.
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 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.
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.
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.
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.
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.
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 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.
Antibiotics consumption	Through study completion, an average of 28 days	Measured by type of antibiotics.
28-day survival	28 days	Number of survival participants

Trial Locations

Locations (1)

Eva Bonfill; 🇪🇸 Barcelona, Spain