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

Eva Bonfill1 site in 1 country198 target enrollmentAugust 2024

ConditionsDecompensated Cirrhosis Bacterial Infections

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Decompensated Cirrhosis
Sponsor: Eva Bonfill
Enrollment: 198
Locations: 1
Primary Endpoint: Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2024

End Date

August 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eva Bonfill

Responsible Party

Sponsor Investigator

Principal Investigator

Eva Bonfill

Project Manager

Institut d'Investigacions Biomèdiques August Pi i Sunyer

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.

Outcomes

Primary Outcomes

Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.

Time Frame: 28 days

Measured by the appearance of new colonizations and/or infections by MDROs.

Secondary Outcomes

Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.(Through study completion, an average of 28 days)
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.)
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.)
Infection resolution rate with initial and final strategies in both treatment arms.(Through study completion, an average of 28 days)
Days of admission to the ICU if needed.(Through study completion, an average of 28 days)
Health costs(Through study completion, an average of 28 days)
Hospital survival(During hospitalization (until discharge), assessed up to day 28.)
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.)
Probability of antibiotic resistance development during hospitalization in both treatment arms.(During hospitalization (until discharge), assessed up to day 28.)
Rate of antibiotic resistance development during hospitalization in both treatment arms.(During hospitalization (until discharge), assessed up to day 28.)
Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.(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.(Through study completion, an average of 28 days)
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.)
Evolution of score Child-Pugh in both treatment arms.(Through study completion, an average of 28 days)
Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.(Through study completion, an average of 28 days)
Days of hospital stay(Through study completion, an average of 28 days)
Number of rehospitalizations.(Through study completion, an average of 28 days)
Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.(Through study completion, an average of 28 days)
Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.(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.(Through study completion, an average of 28 days)
Antibiotics consumption(Through study completion, an average of 28 days)
28-day survival(28 days)