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

NCT05783661 | Recruiting Phase 4

• 1 other identifier: 2022-001858-33
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Decompensated Cirrhosis; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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.

• 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 colonization during hospitalization and at 28 days in both treatment arms.

  During hospitalization (until discharge), assessed up to day 28 and at 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.

Study Arms (2)

Conventional antibiotic strategies

ACTIVE COMPARATOR

The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona.

Other: Conventional antibiotic strategies

Regimens guided by epidemiological surveillance

EXPERIMENTAL

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

Interventions

Conventional antibiotic strategies OTHER

Treatment according to the local guidelines of the Hospital Clinic de Barcelona.

Conventional antibiotic strategies

Regimens guided by epidemiological surveillance OTHER

Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.

Regimens guided by epidemiological surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eva Bonfill: lead

Study Sites (1)

Eva Bonfill

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Central Study Contacts

Eva Bonfill

CONTACT

+34 932275400; bonfill@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study treatment is not blinded, however the rectal and nasal swabs of the control group will be blinded to the investigator and the participant. In all participants, microbiology department will immediately process the samples (swabs) in order to identify a potential colonization by MDR bacteria. Results will be available in the SAP system in patients randomized to the surveillance group but will remained blinded for the clinical investigators in the control group. Blinding will be broken when the patient completes the follow-up period (28 days).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Manager

Model Details: Patients will recieve: 1. Antibiotic regimens guided by colonization/epidemiological surveillance. 2. Conventional antibiotic regimens.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 24, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

ES (1)