Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
NCT ID: NCT05783661
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
198 participants
INTERVENTIONAL
2023-12-11
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Antibiotic regimens guided by colonization/epidemiological surveillance.
2. Conventional antibiotic regimens.
TREATMENT
NONE
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).
Study Groups
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Conventional antibiotic strategies
The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona.
Conventional antibiotic strategies
Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
Regimens guided by epidemiological surveillance
The experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
Regimens guided by epidemiological surveillance
Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Eva Bonfill
OTHER
Responsible Party
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Eva Bonfill
Project Manager
Locations
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Eva Bonfill
Barcelona, , Spain
Countries
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Central Contacts
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Other Identifiers
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2022-001858-33
Identifier Type: -
Identifier Source: org_study_id
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