Clinical trial NCT05783661: Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
Official title: Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Decompensated Cirrhosis
Bacterial Infections
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will recieve:

1. Antibiotic regimens guided by colonization/epidemiological surveillance.
2. Conventional antibiotic regimens.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
timeFrame: 28 days
Secondary outcomes:
measure: Probability of antibiotic resistance development during hospitalization in both treatment arms.
timeFrame: During hospitalization (until discharge), assessed up to day 28.
measure: Rate of antibiotic resistance development during hospitalization in both treatment arms.
timeFrame: During hospitalization (until discharge), assessed up to day 28.
measure: Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.
timeFrame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
measure: Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.
timeFrame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
measure: Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.
timeFrame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
measure: Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.
timeFrame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
measure: Infection resolution rate with initial and final strategies in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Evolution of score Child-Pugh in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.
timeFrame: Through study completion, an average of 28 days
measure: Days of admission to the ICU if needed.
timeFrame: Through study completion, an average of 28 days
measure: Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
timeFrame: Through study completion, an average of 28 days
measure: Days of hospital stay
timeFrame: Through study completion, an average of 28 days
measure: Number of rehospitalizations.
timeFrame: Through study completion, an average of 28 days
measure: Antibiotics consumption
timeFrame: Through study completion, an average of 28 days
measure: Antibiotics consumption
timeFrame: Through study completion, an average of 28 days.
measure: Antibiotics consumption
timeFrame: Through study completion, an average of 28 days
measure: Health costs
timeFrame: Through study completion, an average of 28 days
measure: Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
timeFrame: Through study completion, an average of 28 days
measure: Hospital survival
timeFrame: During hospitalization (until discharge), assessed up to day 28.
measure: 28-day survival
timeFrame: 28 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Eva Bonfill
Study officials:
References: